Florida Whole Blood Coalition: TXA & Calcium (7/12/23)

All right, exciting times. Welcome everybody. We have a very jam packed agenda for you today.

Just for a few housekeeping things. All of the information you're going to see today, including the video, including the PowerPoint, including some data articles that Dr. Pepe is going to show. All that's going to be available in our public folder that will have a QR code at the end of it. So you don't have to worry. All this will be available. You can R and D all of it. Just for some background for those of you who are joining us for the first time we we started something called the Florida Whole Blood Coalition. The credit goes to first and foremost Dr. C.J. winkler and his team. Randy Schaefer out in San Antonio who started this whole thing and then Dr. Jim Roach chief Heath Clark who we give great credit to because they're really the first folks in Florida to start this and we just R indeed everything from them. And then we said hey, let's start this collaboration and it's really blossomed. We have a lot of people on this call who are the, the leaders in whole blood and the civilian population. And if you're here learning for the first time, welcome.

And again we have a great, a great program in store for you today.

We do have a mission and I think that everyone is pretty much in it for the same reason. You're all here because you want to get the right people around the table. And as you'll hear from some of our speakers today, it's all about setting up the stakeholder groups. Early on you're going to start a coalition, have a mission statement, be sure that you're doing it for the right reason. And you're going to Hear today from Dr. Scott Barani from the state of Colorado who doing exactly that. And he's probably doing it better than we're doing it. And you'll hear from him shortly. Just incredible work is being done across this country. We're at the precipice of something very big here and we'll all look back on this in 20 years and say, hey, we're part of this. So very exciting. We have an agenda here today. So then through the welcomes, each person will introduce themselves as we kind of go along. But first and foremost we are going to have a Great talk by Dr. Pepe coming up here in a few minutes. And Paul, I'll give you the screen share in just a second but keep going.

I'm trying to put the talk together so that'd be great.

Typical Eagle style, right?

There's a lot of questions out there on TXA. A lot of questions. And Dr. Pepe will really unravel all the data and make it clear why you really have to look at the data in a very specific way. Then moving on to calcium, there's a lot of questions about calcium. And Dr. Pepe will give us a nice overview and will attempt to kind of steer us in the right direction, which he oftentimes, that's his niche. Right. He steers the ship and he always ends up at the right place.

If Dr. Meg Marino or Chief Dransfield are from New Orleans EMS, I'll have him follow Dr. Pepe with their update. And you'll understand why I did that in a minute. And then we're going to go around the horn to lots of different places around this country doing some great things. We'll talk about data collection efforts in two lane registry. And if you're not, if you're doing whole blood and you're not in the registry, we're going to hook you up with Danielle Tatum, Dr. Danielle Tatum and Dr. Wanda Chesney. We're going to get an update from another visionary, Dr. Ken Shepke from the state level. And then Dr. John Kramer is going to talk to us about a really big thing. He's starting at the federal level, which is just incredible to me. And then we're going to finish it off with.

The person who started all of this, along with Randy. But Dr. C.J. winkler will join us. Without any further ado, I'm going to bring in Dr. Paul Pepe, who's been a mentor to me and many other people across this country in this field of EMS. So, Dr. Pepe, can I have you share your screen?

Anyways, whenever I had to make a decision about what our protocol would be or what decision I would make in a particular patient on scene or whatever it may be, or in the emergency department. I'd always say, if this was my family member, this is my daughter, if this was my brother, what would I do? And so, and this is, you're going to see, this is what I would do as we get along here, particularly with respect to txa. All right, let's roll. So as I call it transitioning to transaxemic acid, I was supposed to give this originally at the Eagles meeting and we never had a chance to get it. But. And I was going to come on as Dr. Reddy Whipp there. So we'll see how it goes. All right, so disclosures, right? All the coffee beans. Columbia wouldn't make Me, a morning person. That's the only disclosure I have and I'm non essential as well as everyone knows. We actually published on this with John Jew and John Holcomb a few years ago about non mechanical hemostasis and trauma. And that included various things not only giving blood but also giving TXA as well. And we then later did an update on TXA and tbi. The bottom line here and Jim Roach, who of course has been so instrumental down here in South Florida getting things going here with blood was on that with us. And bottom line was.

It really is, you know, it's nothing has changed in my mind since then and no other data have come up to change what I'm about to tell you. Okay, so JSON published the the GCCC proposed change in 2022 for 20 to 2020, 20 to 22 guidelines where they said down the road the most significant updates to the guidelines are including significant traumatic brain injury as an indication for txa. And I will mention that today. And although we're focusing on hemorrhaging Pat.

This goes hand in hand with the hemorrhage guidelines as well. The issue is to change the dosing as a single emphasized single 2 gram IV or IO administration and then we're recommending it as a slow IV push. And we all have made different interpretations of what that is as we get along here. This all got started with the Crash2 study many years ago, published back first in 2010. The thing that's interesting about this paper is that they, their protocol said that what they did was they randomized people within eight hours of injury and they had a loading dose of gram over a gram over 10 minutes and then one gram over eight hours. This is going to be the key point. This all got started because people would give a loading dose when they're doing certain cardiac surgeries or other types of surgeries back in the 60s and then they would give this over the next period of time while they were still operating, etc. So the interesting thing is that that's what people have used to apply to trauma, which we in retrospect think was not a good. So when you hear about me talking about the one plus one, I'm talking about one gram up front and then one gram over the next hour several hours. In this case, you see here that they also went out to 40 countries and they actually found a difference. Now the differences were very small in terms of the outcomes, but there was some positive difference. I'm about to tell you why they had some positive difference. Because in they gave just not to bury the headline. When they gave it very early on, that's where the better outcomes were showing up. But I'm going to show you that here right now. So overall they said, hey, we had better outcomes here. As you see for bleeding deaths, early TXA treatment is better. And on this side, this is better outcome versus worse outcomes on this part of the slide. And Peter, can everybody see this? Okay, am I showing you?

It looks perfect.

Yeah?

Yep.

Okay, good. So this is the overall outcome and that's the problem. People always take the bottom line, the yes or no line, without looking at the data and breaking it down. And so what happens is it turned out that if you actually. Oh, sorry about that. If you actually got treated within an hour, look at this, your chances of dying was 0.7, you know, like 70, you know, 0.7 chance of dying over, say if it's a one to one ratio, you know, you're saying your chance of dying is only 2/3 of that of what it normally would be. And so, and so that's what pushes. But that means this is a balance of something else. Okay, and that balance of something else was that over three hours, if it was given late, you had worse outcomes. Now why would you have worse outcomes? And again, we're going to talk about that in just a second. Well, the worst outcomes is attributed to the fact that it's, it's a thing that causes you to clot. If you live long enough to have clotting associations, you'll have risk of problems. And this is what's interesting is because at first many of the surgeons had been not accepting it, whereas military people were. Many our trauma surgeons weren't because when they did the studies in the hospital and person lived long enough, they actually had more. They started seeing these complications. All right, so, and that's totally understandable. And again, where I'm going to be going to is that if you give early, and I mean really early, it's, it's a good thing. There may be some complications, but you will have a better chance of living if you're in a position where you have to get this. It's that as time goes on and you give it later, then the risk benefit ratio flips where risk is now much higher, etc. And that's going to be my main theme here. But I'll go ahead and give you some of the data. All right, so again, let's go back to this. If you give it here within an hour, and that is what made A difference. So which way do we go? All right. The really cool thing is that we started understanding this and right about that time, people like Dr. Marty Shriver, who did a study on head injury cases, okay, following one also that was called Crash three, by the way, which showed kind of similar results. It sort of, kind of, yes, it's a little bit better, et cetera. But what really came down to when Marty did his study with the ROC Resuscitation Outcomes Consortium, he prospectively asked, we're going to see what happens if you had a person with a head bleed. In other words, if you later document they have a head bleed, let's see how they did in terms of their survival, et cetera. All right, that's Dr. Driver right there. So this study published again in the jama, you know, overall didn't show a real significant difference between it because they lumped everybody together. And one of the things I'll tell you is that they lumped the one plus one grouping with a two grams right up front group. So everything was kind of mixed together in those two groups. You'll see why that becomes really important as we go along here. But when they did look at the specifics thing of this 2 grams versus 1, place versus placebo, so they had the, the wisdom to look at this in terms of three arms. You lose a little statistical significance, but still, two grams versus one plus one versus placebo. And they looked at moderate to severe TBI cases. Okay. In this particular situation, what was interesting is the median time. That means half the people got it within 4, 40 minutes of the time of the injury. So that's pretty significant. And it goes along with the line of what I've been thinking, what the TCCC people have been thinking, that my mantra has always been the earlier the intervention, the better results. And this was getting pretty. That's pretty good to get it in half the patients with that period of time. And the other thing is that nearly 60% of the people later were found to have an intracranial bleed. And then of course, that MEANT There was 44% without, which by the way, is a nice built in safety cohort. In other words, they didn't have any bleeding in their head, and yet they got this and didn't hurt them and just not the, you know, the jump ahead. It was perfectly safe to give it to them under these circumstances. They didn't have more complications or anything like that. So the overall results again were 65% plus versus 62% for the controls. But remember the 60, the 65% thing lumps both the people with, with head injury, without, I mean, sort of with it, with head bleed, without head bleed. And also it lumped in the ones that got the one plus one. You know, they put it, they just lumped them together in that primary thing. But when you examine those with CT confirmed intracranial bleed, the target group, from my point of view, right, there was a 16% mortality with the 2 grams up front. Okay, and look at this. When you looked at 27% with the one plus plus one infusion versus 26%. So mortal fluidity rates were about the same for the placebo plus the 1 plus 1 gram versus the 2 grams up front. And this really started pushing me even further to being aggressive about saying, if it's going to be more than an hour, I may not even want to give it. And certainly I don't want to give a infusion over the next eight hours. If this was my family member, this is how I feel. At this point in time, there was a slight risk of more seizures, but you have seizures anyways. It's like they had 13 seizures versus eight seizures out of the 300 patients that were being examined. But, but there was no other increased complications. And it was, they, they did fine long term. And so it was deemed to be safe from that point of view as well. So let's go back to this. What it really tells us is that this thing is what we need to concentrate on, the less than one hour thing, early treatment, less than one hours is much better. And avoid going, by the way, and avoid going here. And particularly I'd like to avoid going anywhere out towards over an hour from my point of view, right? So now when you look back at Crash three, okay, and that circumstance, same kind of stuff starts showing up that your chances are dying. This is like 60%, you know, there was 40% less. It was only 60% of what it normally would be. And especially if you got it done, this is treatment, you know, within the first hour here. This is minutes to treatment. So they did have a relative risk ratio that was much better if you, the earlier you gave it, the better off you were. In the ROC study that I just talked about there, what was interesting, the early time, less than an hour to therapy with 2 grams improves the outcomes pretty significantly. And so that's what you see down here. Now this is a time in days, so we're talking about the hour thing is in here. But you can see this is extremely low when you get into this, you know, first quarter hour, half Hour, hour period here, etc. It's all showing the same thing. This is the bolus only group, the 2 grams IV up front. And now here's your mortality rates out here with the placebo and the bolus maintenance group. All right, so when the stamp trial came out with Frank guy at and his group out there, same kind of stuff shows up. Favors, favors transact, they give one gram and then they gave one on the arrival at the hospital, which usually generally there was within about an hour by the they pointed out to me and again all this stuff started favoring the, the, the trans examine group here. And the same thing. If the time from injury is less than an hour, they did better. And then if the blood pressure less than 70, obviously the people who are sicker, much better, et cetera. So better with higher dose, better with treatment within an hour and especially if you presented with hypotension. So anyways, when the article that just came out about a week ago out of, you know, you might ask, well, what do they find there? One of the interesting things about the Patch trauma group, which is came out of Australia primarily.

I knew the results of this by the way, about eight or nine months ago because they consulted with me and talked to me about it because they were getting ready to write the paper up. And I said before you tell me the results, I just want to know one thing, what was your protocol? And they said 1 gram IV followed by 1 gram infusionator. I said, you're not going to find any difference or it may even be worse for all I know. But and it depends, and it turns out only about 20% of their people got the drug within the first hour by the way, in this study level, the fact that they did the protocol with a one plus one, there were no, there was not the two grams up front and as predicted, you know, it didn't show any difference of that kind of thing. So it was very, very interesting that it said right now I was able to predict what their outcome was going to be without them telling me, just based on that alone. So in summary for the txa, and I hope I haven't gone over too long here, Peter, is that there are better outcomes, but only if given early as a 2 gram bolus. As far as I'm concerned, it's safe if it's given early and also it's likely good for all trauma, including internal bleeding and TBI cases and then we can talk later about giving it for other bleeding cases, obstetrical and so on. But that's the reason why most of our protocols down here in South Florida do go this route. I know you mentioned San Antonio and there's so many others that's the same way we've been doing it, the same approach here and by the way, haven't seen any particular issues coming out of this that have been a problem that we have to note. Someone will have to clue me in if there is anything else to be known about here. So again, coming Back to it, 2 grams IV IO administration. Some people have asked me, by the way, about giving immigration. And one of the things that a lot of us worry about there is, I guess it's better than nothing if you're in a tough situation where you're, for example, I don't know, pinned in, in a tactical situation, but your blood flow may not be so good, so maybe it doesn't absorb as well. You know, im those studies are actually kind of going on. I mean, they may already be published and I don't have the data, but that's one thing. The other thing is that places like San Antonio actually will give it early on. Just, it's a logistical thing because as they're getting the blood up and ready to go, they want this on board as soon as possible. And we try not to mix the two. And so. And I think that's pretty much what I want to say about that for now. And then, Peter, can you just add in TXA for kids? Should we not give it to kids? Should we give it to kids? What's your protocol say?

You could probably guess that we do give it to kids. We treat them just the same as everybody else. Nothing magical happens when you turn 18. So yeah, we give 15 milligrams per kilogram and there's lots of data on that. And actually the data from the military demonstrates that TXA in children does have a positive impact and reduced mortality. So just like with whole blood, please have a whole blood policy or protocol for children. And also if you're using txa, do not exclude the kids as well. So that's my two seconds on that.

So, Peter, you have a protocol, I think starting around age five or something like that. How about if it's a three year old, you know, and they're bleeding, you know, and it's not good. Yeah, so accident on the beach, whatever, that kind of thing. Right.

The protocol allows for whole blood in all ages. It's just that. And we're, we're not a mother, may I call the medical director? Type of people. But for this particular Thing under the age of five. It's just a call to the medical director. The dose is still in the app. And so, you know, before launching this protocol, I looked at five years of data from our children's level one trauma center. And in five years, we didn't have one child who needed blood in the trauma bay under the age of five. Although there are stories from other. Other places that do have that. So it's not that we exclude under age 5. It just requires a call, just so we're aware of what's going on.

And that's for TXA as well, though. That's what I was asking.

No, I. No.

Okay. I just wanted to ask that. All right. Does anybody have any questions of me? Do you want to.

Yeah, Paul, let's. Let's keep going. Only because we have a tight agenda. So if you want to, then we'll ask questions after you do the calcium.

Okay, good. I'm fine with that. I just want to make sure. If anything wasn't clear here, let me know. Okay, so thanks. So, in conclusion, I think we're gonna get back more people than we did before, so how about giving that pre hospital with transfusions? So what I'm going to do is why would we do this in the first place? Two, should we use calcium chloride or gluconate, and what route should we use? IV IO IM. Pros and cons on doing it pre hospital vs in hospital. And then some of the general questions that we don't address so much today, but just to know there are effects on the heart phosphate levels, the, you know, the. The microcirculation and various things that we have yet to explore. And there's even more things we're going to talk about in terms of trauma itself causing hypocalcemia. All right, so let's go to the why. So the why is that things like EDTA or citrate, which are calcium chelators, are used to stop the clotting, to store blood. If you take out. If you absorb up calcium, you actually create a more of a pro, you know, a less coagulated environment. So you can. This. These numbers might be wrong depending on what situation or what is. But let's. There's a certain amount of this. This stuff is added into it. So usually they'll give you 3 grams of citrate or 1.6 citrate, plus some other calcium binder, and that's. And then of course, if you have to, then break it down further, like into RBCs, they might have to add let's say 40 mils more. So that's 80. And if you're given two packs of red cells then you might be g lot of citrate and it can, it depends on the formulation. You know that for example, if you're having one that lasts 30 days, you might have more if you have. So those are all things that are right there. And in fact I know Randy Schaefer, if you make like a 10 second intro, isn't that sort of the case from what you found is different? There may be depending on how long they want to store the blood for, there may be different dosing of these kinds of chelators.

Yeah, if it's CBD versus CPDA one and the first one is usually a 21 day life cycle and the second is a 35 day. I do not know enough about the difference, but I'd be curious to see if there is some. So I'm going to start looking that up.

I would just say that the main thing is be aware of this by the way and you might want to find out in your area, you know, you know what, what they're using and how they're using, et cetera. So just bottom line though, it doesn't matter. It's lowering the calcium and once you get to your bloodstream, it lowers it even further. All right. And then also there's free floating citrate in your bloodstream. So and what happens if you're injured, like you have a damaged or poorly, poorly perfused liver where it's usually metabolized, the levels of citrates for example, could go up and then you have toxicity from it in the sense of really taking out more calcium, etc. So you got the general idea is that you are at risk for it, but the interesting thing is that you actually can get it from the trauma itself. Now I'm not absolutely sure why this happens. My personal belief is that it's related to the fact that when you get into an acidotic state, you're producing a lot of H positive hydrogen ions and so it competes with the calcium, may drive it down. And so as a result you may have. There may be other reasons that I haven't dealt into yet. I'm just learning more and more about this. But even so, without giving the blood, you could find that you're hypocalcemic in some of the cases that we're talking about here who are at risk. So a concern. So more and more I've been thinking this is what we need to do. But what's the treatment? Should you give calcium chloride or calcium gluconate? Well, it turns out that in theory, anyways, calcium chloride might be better because you get better free calcium ions out there right away. Or is that a problem? Actually, you know, because you affect other things. Because once you put calcium out there, you will affect potassium levels. You'll affect all sorts of other things as well. But probably in this case, because you're so hypoglycemic, de facto, whether you've had blood or not is probably, you know, it says that takes some of that worry out. But there also is a risk for sclerosis, meaning that if you get it into like a peripheral IV site and it extravasates, leaks out, you could cause really bad sclerosis in that area. And then, Peter, you. You have a case in which it was an injury to the leg, but they try to. Did they give it into a vein in the leg or how happened. But I heard that there was cases where at some hospitals they had an amputated kid's leg when they gave this. And so as a result, they switched over to calcium gluconate altogether. Is that right?

Yes, that was a pediatric patient and the child did indeed require an amputation. So they just.

Was it a leggard arm? I'm sorry, I didn't know about the amputation. I'm sorry that I didn't know that. I was just thinking badly leg. But it probably was arm. Right where they probably gave.

It was a leg.

Oh, and they were giving. I. They gave the IV or whatever through the leg or did it.

I'm not sure if. I'm not sure if it was a central line or an IO, but it was right lower extremity.

Right. Anyways. But, you know, theoretically, if you got a good IO in, by the way, it's fine to give it that way. There's not a problem with this, you know. And then of course, we have emphasizing femorals and in humerals, maybe in adults. But here's the problem. Did you get it in? Did you enter right place? Will it cause a problem like we've seen here that we're not sure about? So there's a lot of questions out there about this. Okay, so bottom line is that when you look at the joint trauma system recommendations, anybody can look up, here's their quick reference guide, and I'll pull it up a little tighter. It says to prevent hypocalcemia related to massive transfusion, moderate monitor ionized calcium, administer it early, et cetera. But Just jumping down here, it says that calcium glucose is preferred for peripheral IV administration. In other words, that you really have to have a good central iv and if you're going to give it calcium chloride. So you may be saying that may be the way to go and it may be the preferred way to go under these circumstances. Okay. All right, so now what's the pros and cons of pre hospital? So most of us have thought, hey, let's just get it when we get to the hospital because we're only given a unit out there. But when you consider the fact that maybe you're just getting hypocalcemia from the trauma itself in these patients, maybe that gives you some pause and think maybe immediate treatment is good after all, versus the hospital arrival where you can get a central line in all those kinds of things. But one of the some people would cite, and I don't know if David Miramante's or CJ here could comment this is that part of it is also you need an extra iv. So it's logistics and maybe it's the time issue and let's just do it later on or go in hospital and then in the hospital you'll have the ability to check for calcium phosphate levels, potassium levels and all that. And someone would say, by the way, there's no proof that that gives you a better chance of living. They give it pre hospital. I think there is enough data and we're going to send you some papers to say your chances if you let the calcium go, if you if the persons have hypoglycemia, it's associated with death. So presumably treating it would be a good thing. But so giving it pre hospital, does it make a difference? We're not sure yet. But I'll tell you what, as I've learned more and more about this over the last few days, and I'm going to learn more and more, I'm leaning more and more towards giving it in that pre hospital setting if it doesn't delay things and using gluconate. So we avoid all the other hassles that we were just talking about with the calcium chloride. So in conclusion, the answer is do give it pre hospital or don't give it pre hospital. And that's everything today. If you're giving it, like Eric Bank I think is on the phone, that you guys have been giving it for IV calcium chloride for, you know, years. So the bottom line is that you, you could give it and I wouldn't have a problem with it, you know, and if you Wait till the hospital. Right now, I don't have a problem with it. Although I will admit when we talk about which way do we go, I'm starting to lean more and more pre hospital as I always have, so. And then with that on the road to 22nd century, I hope we'll make life better for future generations. And I'll take questions now. How's that, Peter?

Awesome. That was a great, great presentation. Thanks for summarizing the data which.

Stop sharing. Okay.

Oftentimes this data gets confused by people who are just reading it on Twitter. So let's bring in Chief Eric Bank. Chief, Dr. Pepe called you out on that. What are your thoughts and how, how's it been going for you in, in Houston area?

Yeah, so we haven't had any problems. So we usually do it. We do the 2 gram TXA up front, flush it, run the blood products in, and then after the first unit of whole blood, they get an amp of calcium or a gram of calcium. And we haven't seen any cardiac effects, any ill effects.

You know, obviously we do kind of emphasize that it needs to be a good flowing IV or IO. But again, we're given blood first, so we're going to know that IV is functional before we get to the calcium. We just stick with.

Yeah, you don't know. That's okay. And I just want to make sure as you're on that point is that we don't mix the blood with the calcium. Okay? Correct. So I just want to make sure. Absolutely, yeah. People are not. So. So the point. And then you do give calcium chloride, is that right? I want to make sure. I emphasize that. Correct, Correct.

Because that's what we already carry. So instead of carrying two different medications. So if we do actually switch the gluconate, we'll just switch completely over. But right now we're still carrying calcium chloride.

Okay, good. Thanks. Thanks very much.

So Paul, let me, let me bring in Chief Tom Dransfield from New Orleans. Chief, are you there? Because I know that During Paul's talk, Dr. Pepe's talk, he mentioned that if you use PAC red cells, then you should give calcium. And you in New Orleans are using packed red cells. Can you comment on what you do and how it's going there?

Yeah, it's. We've been using it ever since the inception of it. And we do the, of course, the PRBCs, they're 300 mils versus the 5. So we have the same standard loadout that everybody else was talking about. We give the blood and then the calcium and then the TXA is basically the batting order we give our guys to do it in. We prefer a second line or a second route or access for the TXA and the calcium. So the blood is a dedicated. A lot of times it's not. That's all we can get is one access through the IO, so they flushing it with at least about 20 mils is what we recommend. In between the blood and the txa, or the calcium and txa, so we.

Can get that out of the way.

But we haven't had any reports. Dr. Tatum's on the call. She's with the university. She might be able to shed some light, but we haven't had any feedback about any ill effects or anything from our calcium administration. And we use the calcium chloride as well, just like Eric was saying, just because we already had it and we were keeping it simple.

Thanks. Thanks, Chief. So, Dr. Tatum, he called you out there.

You're.

You know, I have you later in the agenda as part of the two lane registry. And thank you so much for that. You have any comments on what the chief was saying?

No, I'll just apologize in advance for not being Juan. Sorry.

He's okay.

No, in the air. On his way to Puerto Rico, I think. No, Tom's exactly right. I was actually, I didn't. I was lecturing before, so I was a little late and I didn't see Tom was on. I'm glad he's here because he's the, you know, the authority. No, we haven't seen anything. And New Orleans has been giving this as a bundle, so it's. It's our resuscitative, you know, advanced resuscitative care bundle. So like you said, it's the 2 grams TXA, 2 grams calcium. And most patients are getting two units of packed cells in the field combined with the short transport time. So our results look pretty nice. If you're just looking at mortality sample size wise from statistical standpoints, we could use a little bit more power to sort of look at, you know, any complications or anything like that. But so far there's been nothing to indicate that this 2 grams of calcium in the field is causing any adverse effects. If anything, it might be more protective. And sometimes I wonder, I was like, are we giving enough calcium? How do we know how hypocalcemic these patients are? From the trauma itself and then from the chelation of the citrate in the product. So we're actually looking to compare some of these things in some upcoming studies, but I don't Want to spoil my whole spiel for later?

Hey, by the way, do you do any red tops, like collect a sample the blood before you come in or give your blood or maybe that's something that many of us could consider if it's possible or feasible.

We don't do that because back in the old days when been a medic forever, we used to draw blood for the hospital and everything. They just traditionally don't take it. They don't think it's clean, they don't want it.

They.

They just would throw it away.

So.

So we don't do that anymore.

Although we could make it part of a protocol going forward. But let me ask you this, Danielle, while I got you there, you know, as our, you know, our representative surgeon here, the issue of hypocalcemia, pre blood, you know, the words. And getting from just trauma alone, what is your understanding the mechanism or do you. Poor understanding as I do. Right.

Yeah, I think we're in our early days in that. Right. And so one of the things I think we're kind of lacking is really understanding how hypocalcemic these patients are. We're saying hypocalcemic, but it's a continuous variable.

Right.

It's not dichotomous. It's not. Yes. No. What are you chasing? And I think that's a question we should start trying to answer. Measuring ionized calcium is real hit or miss here, and sometimes it comes after the transfusion's already started. So if you compare it to patients before they got blood. And what are you really looking at? You've got apples and Volkswagens, and so it's not a good comparison. So I think that would be a great thing to look at in terms of. And can we do that in the field? You know, can we get point of care type calcium assessments up front to know what kind of, you know, rabbit we're chasing here?

Well, before. Get me off the stage. But I do want to say, does anybody have a descending viewpoint from.

Dissenting viewpoint from what I put out there today or having, you know, disagreement with it? Because I'd like to know that and try to have an open mind about what I put out to everybody there.

And if somebody does have a comment or you want to just put it into the chat, you can always contact me afterwards and I'll make sure Dr. Pepe gets the message. But Paul, that was phenomenal. And clearly there's a lot of discussion around this topic. As usual, you're ahead of the curve on it, and we appreciate you kind of trying to point us in the right direction. And with Dr. Tatum and many of the others who are either doing or not doing calcium, I think with the two lane registry involved, we'll be able to get an answer on this hopefully in the coming year. So thank you so much, Dr. Pepper.

Yeah, thanks for putting up. Hey, do we have CME on this thing or is it without.

You know what? Not. Not today, unfortunately. I apologize for that. It's my.

Okay, we can work on that for the future, but that's it. Hey, Randy, can you. Let's have. By the way, Randy, why don't you pipe in? I forgot Dr. Jenkins is doing a study. Yes, tell us a little bit about that.

Yeah, so after we talked yesterday, it started generating the wheels. There's some random military publications that are put out that it's really hard for you all to find online.

Right.

I forgot I had one of them.

So there is currently. The study is called calcium and it stands for clinical assessment of low calcium and trauma. So the three site study with Brook Army Medical Center, University Hospital and up in Colorado at the trauma center up there. And they're going to look at indeed all the things we talked about with the impact of calcium on trauma. We're going to measure it at. They're not doing it pre hospital. In this case It'll be arrival 3 hours, 6 hours, 12 hours, 18 hours and 24 hours after trauma.

All right.

Okay, very good.

Is it gonna be St. Anthony's in Denver, I assume.

I haven't read that far yet, but I can do an email with Don Jenkins. He already wrote to you while we were talking.

Oh, no kidding. Okay, I'll go take a. I'll give him a shout. All right. Listen, I better get off. Peter, this has been kind enough to give me all this time. I appreciate it.

So perfect timing. Thank you so much, Dr. Pepe, for that. I'm getting some messages. If we can get a copy of the presentation at the end, we're going to give you a QR code. You'll get everything, so don't take pictures of your screen. Alrighty. Moving onward, we are now going to go around the horn. We have a lot of great people on this call, people who are spearheading things at their departments. But I really want to bring in first is Dr. Jim Roach and Chief Heath Clark, who I give the credit for. You know, years ago they said we're doing whole blood and. And they did it. Broward Sheriff's office. Very large EMS system here in South Florida. And so Dr. Roach and Chief Clark, would you mind coming up on the stage and giving us an update of what's going on in your neck of the woods?

I made it back just in time, I guess.

Can you guys hear me?

Yeah.

I don't know if Jim keep making on, you know, his schedule lately has been kind of crazy. Yeah, we added TXA earlier into the year. We kind of slowly, slowly rolled that back out. We started with blood first, which I realize is probably backwards compared to most people's experiences. Update on numbers. Right now we're at 116 applications of whole blood products and our 24 hour survival rate for that is 73%. Working with our hospital partners right now to start collecting the data for the 30, 60, 90 day outcomes. We'll be talking to Jim about how we're going to pursue documentation and studies and so on and so forth. I know Dr. Pepe will be involved with that. Dr. Levy will probably be involved with that. We're going to try to utilize as many resources as we can. But I mean, all in all, if any of you are new to this, I can tell you wholeheartedly that this is an incredible project. I highly recommend that anybody is not pursuing it if you don't have it in your region, that you try to put it in your region. And I can tell you that I miss more cases than I actually deliver on due to staffing issues. Half of my product is kept on a helicopter. Obviously it rains a lot down here in South Florida, so we have weather limitations. We also, because of the nature of helicopters being what they are, we have mechanical limitations at times. So that sometimes reduces my level, my level ability to access my patients. And then I have one terrestrial based EMS officer that also carries whole blood. The issue There is it's 400 square miles and it's a regional unit, so can't always necessarily get to where they need to be, unfortunately. But even with that, it's almost 120 some odd cases.

Had a significant impact on many, many people's lives. And I think we've at least anecdotally proven that this is worth reinvesting in and expanding. I think the powers that be within my agency and with the count within the county are starting to take notice of what we're doing. I have a news piece, local news piece, starting on Friday. I'll be getting interviewed, so that should be interesting. Haven't done that in a long time. Hopefully this one goes better than the last one did.

But it's starting to gain traction down here and I think that when we speak about it, enough people. And a lot of credit, of course, goes to Dr. Roach, Dr. Antebe. There's been a lot of people that have actually been carrying this torch and trying to make people pay attention to what we're doing. And they said it's a very special thing. And despite my logistical issues and whatnot, we've had a dynamic impact. So if your system's a little more compact, because I can tell you that one of my issues is we are. We are. We're not one sole entity. We're not just a city. As the county agency, we contract throughout this. Throughout the county with multiple different entities. And there's often very big coverage gaps with municipality fire departments between us, who we work with very well.

But it.

It can slow things down when it comes to actually providing coverage.

So if you're working off of one, one can, you know, concise. You know, we'll say Fort Lauderdale, Florida. They're right next door to me. They're a big department. They, you know, they would probably be very successful based off the fact that everything they do is kind of centered in one area. So I know a lot of people look at the initial expense or the commitment of manpower or personnel, however you want to look at it as being cost prohibitive. I would caution them to look at what it actually costs to actually run the program and really look at it. When you extrapolate it out, I mean, if we're looking at me, $1,000 of application, whole blood, you know, that's cheaper than running a code. A code. And we do that with our eyes closed. And quite honestly, anecdotally, the blood seems to be more effective. So if I can do this and I can be successful with my unique operating situation, city departments, absolutely can. So I am a big proponent of it. I'm not always as readily available as I would like to be for questions, but I think we can get my contact information out there. And if there's anything I can do to provide any further information to anybody on what we're doing, what we have found that has worked, what hasn't worked, what we would like to do, I'd be more than happy to share with anyone.

Well, Chief, you've done so much, and I know that you're busy, but you've done some great work and we really appreciate you. And Dr. Roach, we are going to rope you into a potential concept of education for the state of Florida, similar to what San Antonio is doing. So stay tuned for that.

Speaking of state of Florida, let me bring In Chief Charlie Coyle, who is incredible, our EMS chief at Palm Beach County Fire Rescue. And I've asked Charlie to really talk about our update at Palm Beach County. But I also wanted him to get a little tactical because he's so good at putting together a process and then evaluating the process in an ongoing fashion and sometimes in a day to day fashion. He's incredible. So, Chief Coyle, please, please join us up on the stage and give us the update.

Hey, Dr. Antevi, thank you so much. And thank you for putting up the slides. Much like Peter Antevi fashion. I found out about 15 minutes before the talk today what I was supposed to talk about. So any good Peter Antevi talk is done in the parking lot before you walk in. So one of the things Dr. Antevi asked me to talk about today specifically was, you know, Palm Beach County Fire Rescue, we cover a lot of ground, so we're 1800 square miles. We have 50 fire stations. And daily I have nine EMS captains that work as an EMS supervisor. So the question that he had for me was, how do we figure out where the blood was going to go? So when we first started up our program, we have two helicopters, we have nine EMS captains. Where do you put the blood? So a couple of the things that we looked at specifically were our battalions, which is on this map that shows the H's on it, where the hospitals are. We have two level one trauma centers, and then we have it broken down by battalion. So specifically what we wanted to look at is we wanted to see dramatic cases. And then we used the criteria for the protocol, and then we just used a heat map, a GIS map, and then we just plopped the dots down on the map. So what we decided was we were going to start with a formula saying that, number one, how many patients were in that little area where these battalions respond. And then number two is what is the proximity of the trauma center. So we started out at one battalion. You know, the picture on the right over there is just basically kind of granular to one particular response zone. And, you know, we started with one EMS captain and then we started with both of our helicopters. So, and then, you know, he asked me, he says, well, what do you do now? How do you expand the program? So, Doc, if you could change it to slide two. And basically this is something that we run monthly now. And this is just basically looking at our, our electronic patient care reporting. And we use crystal mining, our crystal reports, which this is a data mining tool that is very specific, but not as specific as you would like. So essentially we look at our trauma cases, we use our protocol for whole blood and then we extract out every case. But we also look at the incident number because you have to double check the case. We look at the call type. And it's very important to understand the dispatch as. Because we need to make sure that we're putting the EMS supervisor at the actual scene because only the EMS supervisor carries the blood. And then we adjust our dispatch protocols over time. But what this allows us to do is we take this and then we put it on a map. And then as we go to expand our program outwards, then we understand completely what should be the next area of movement that we're going to decide to, you know, implement whole blood and put it on our EMS captain's supervisors because vehicle. And then the last slide is just, you know, basically we had our one year anniversary and I will tell you that this is not done in a silo. I know Dr. Winkler is going to be on the call if he's not already. Dr. Peel, Dr. Holcomb, Dr. Roach, Dr. Antebe, Dr. Shepke, Heath Clark. We have so many people to thank because ultimately you provided us, you know, a roadmap on how to do this. And Basically we had 56 patients total for our first year of operations. This slide here, although appears to be busy, we took all the arrest cases out of this. So we were left with 35 patients. And out of the 35 patients that did not go into any form of traumatic arrest, we've been able to see an 89% survivability. And then if you look, 76% of those patients had a decrease in their shock index. And I could go on and on and on, but I know that our time is very limited today. So again, the mapping the crystal reports how we got to where we were going to put our blood. We are up to, I think four EMS supervisors now. So the way our county's laid out, out of the nine EMS captains, four of them have whole blood. I believe next month we'll be launching in another battalion and we will continue to make data driven decisions here at Palm Beach County Fire Rescue. So again, thank you for the time and thank you for all the people that blaze the trail for us to follow.

Chief Coyle, incredible update and that that tactical kind of overview is very important and if anyone else out there is doing something similar, please let us know. I would love to have you on further on the future webinars because I think that type of information is Also just as important of how to get a program started. Let's move on.

Yeah, I want to ask Chief golf question. Is that okay?

Yeah, go ahead.

Yeah, yeah.

So.

Hey, Chief. Quality, fantastic presentation, by the way, as usual. So. But I want to point out on the issue where you had the traumatic arrest is that one of the things we found early on was that if they were pulseless on our arrival, their chances of surviving were basically pretty nil. And we're going to look at that and see if that's, you know, that could be the case and you can have better utilization as a result. But the other interesting thing is you saw that the, that in the other patients who are pretty sick to get this stuff, they, the way the protocol is now, I even think it should be liberalized is that they were pretty sick. And then you show these improvements and the outcomes are really a lot better than they have been historically. But one of the things about I think is that people should use is that shock index that you pointed out wanted to do that. And I think your numbers would even be higher. I don't know. Did you delineate the people who are crashing, for example, if they had a pulse of 70 along with the blood pressure sub d. Right. Because they were crashing, that's a, a initial shock index of one and some. And I've seen where you fix those people, by the way. So, you know, that's something to be look at when you look at the shock index because your data may be even stronger than you think. That's, that's that commentary. Any reaction to that?

Yeah. So essentially, if you look, it's kind of odd because in 4% of the patients, the shock index actually went up, not down. And that's because they were so bradycardic when we got there. So exactly what you're saying, Dr. Pepe, of course, you know, we can't pull any of the, the tricks on the data with you, but that's exactly what you said is exactly true. So a couple patients were extremely bradycardic. They got the blood, their heart rate increased and their blood pressure did stabilize as well. But it looks like the shock index went the wrong way and essentially it actually was just bringing the patient back to life. And the shock index was a poor indicator of that.

Fantastic. That's why I wanted to bring that out. You know, and then the other thing I was going to say is one of the things I'd love to see you do in the future. We'll talk about that later offline is, is looking at the Time from the incident to the time you gave the blood. Is that a factor? There's so many other factors though. It'd have to be probably in a regression analysis. But I think that's a good thing because I hear people saying, well, we're so close to the hospital, we'll just get the blood at the hospital. And I think every minute counts out there with the type of patients you've been treating. Okay, that's it.

Great discussion. Appreciate that. That's fascinating. The, the bradycardia and the shotgun. I love that discussion. All right, moving on. So I'm now going to bring in someone who took on an entire region by himself, I'm saying by himself. But obviously he's great at building teams. But we're going to move now to David Long from the Tidewater EMS region in Virginia. So David, tell us how things are going and please give us an update.

If you can see my screenshot, you'll notice that there's an interesting background. So I just happen to be on vacation in Kona, Hawaii. So Aloha.

That said, I guess what I tell you about the Taiwaner EMS, you know, program at this point is that we're 10 months in. So we are 29 cases thus far. So 18.

Of the 11 have, or 18 of the 29 survived discharge. So that puts it about a 62%, I think, for our survival rate. Like Chief Coyle mentioned, we're all right around that 73%. So it is interesting that when you look at these, these different programs from, from Broward county down to Palm beach county. For us, a lot of the, a lot of the numbers, you know, within, whether it's 2 percentage points and et cetera, seem to be tracking, you know, almost the same. So we, we were able to successfully span and expand into the city of Chesapeake. So we have city of Portsmouth and the city of Suffolk here on our horizon. We'll be moving to pediatric administration in September and we'll be using the five years of age to 12, along with the popular hand heavy app to get that done. And then we are in the process of doing a, an IRB on the calcium issue. We believe, you know, from data that we've called in region that none of our healthcare systems essentially administer calcium chloride unless it's through a central line. So when we started looking at some of the safety and efficacy, you know, related to, you know, treating our patients, particularly in the pre hospital environment, you know, we understand the potential risk that we take, you know, administering calcium chloride. So I think our program will Actually, you know, stick to the calcium gluconate when we implement that, and we're expecting to do that. I think the first part of 2024 and on the TXA is kind of a question for, for Dr. Pepe. But one of the concepts they're currently discussing is essentially the rollout of. So we use a regional.

What I would call kind of a community drug box system that's supported by the healthcare systems here in region. And we've been talking about putting TXA and all of those drug boxes because we can't put blood everywhere. And if it turns out that, you know, based on.

You know, assessments that TXA would be appropriate for administration, knowing that you may or may not get whole blood, would that be a favorable use of TXA versus, you know, not carrying it?

Oh, you want to take that.

So the question is, is that if you weren't able to give the blood, but it's a patient where you think they're bleeding to death, you know, should we give it? And the answer is yes. It just like if we were talking about giving it for the OB patient that we didn't have blood for or the, you know, whatever else it may be, the head injured patient, for example. Right. So, but again, my, I'm almost adamant about it. It's got to be done within that first half an hour to 45 minutes, if not an hour or else, then I think that it starts reversing. Others may disagree with me, but I'm just trying to emphasize that the earlier the better. Then after that, it's up to, you're right, people will be right to say it may be harmful at that point in time. Okay.

Does that answer your question, though?

It does, absolutely. So I think it fosters our position, Dio, that that's likely the direction that we will head. And that would likely be as first part of 2024 as well. I think the other, you know, caveat is that we've, we've been approached by a regional Jehovah's Witness community and they're aware of the TSA kind of as an alternative to blood products. So they're pushing hard on us to provide that as a, as an alternative for them.

Interesting. Okay, good.

All right, David, thank you so much. Please go back and enjoy your vacation. Your wife is probably like, where'd you go, buddy? So you may need to flood yourself in a minute.

But hey, first of all, I have an important question. What time is it right there, David?

It's just before 8 o'. Clock.

That's what I thought thanks for getting. Okay.

All right. So maybe he's having a Bloody Mary. All right, all right, all right. Awesome. David, thank you so much. Next is someone that I've never met in real life, but I, I can't wait to because what, what, what he's doing is something pretty incredible. We got a bit of an update yesterday from Stein Bronski, but I want to bring in Dr. Scott Browning from Colorado, an ED doc out in Colorado who is putting together a coalition statewide in a very robust fashion. It seems just like a very beautifully done thing. So Dr. Branny, thank you for joining us today. If you want to join us and give us the update from the great.

State of Colorado, I would be happy to. And again, I am just a small piece of this machine we've got going here. I know you got a chance to hear from Dr. Bronski. What what Dr. Bronski and Dr. Angelitis have been doing in Colorado Springs is outstanding, as I'm certain many people on this call are thinking. I'm also one of those people. I blame this completely on CJ Winkler. I was innocent until then, but having attended with a number of members of the Colorado Region Colorado Whole Blood Academy in March, we kind of came away and started kind of grinding some numbers and decided that as long as we were going to go through this degree of pain, it probably made more sense just to try and do the whole thing at once. Colorado represents a geographic region that's about four times the size of Strack. There are some similarities. We're about 40 to 50% of our counties within the state are either rural or frontier. We've got about 5.8 million people there jammed into a, a 200 by 6, 200 mile by 60 mile strip, pretty much jammed up against the eastern kind of front range of the Rockies. So we have some geographic similarities. But then we get to throw the Rockies and winter weather in. On top of it is a modifier even for what you guys get to experience in South Florida. I don't get to worry about hurricanes though, so I'm pretty, I'm proud of that part. And so what we have been doing, we are still at a assembly stage from this standpoint. Our timeline, to be honest, is probably first pilot blood out in the field by somewhere between November and January 1st. Dr. Bronski and Dr. Angelaidis will probably have it at the earliest opportunity in Colorado Springs. Very much in an urban setting like has kind of been already established by San Antonio fire and a number of your guys fire agencies in Florida. My focus on this is I'm a medical director kind of from the foothills of hills going west of Denver all the way up to the Continental Divide. So I'm a little more focused on that piece of how we do an integrated program that covers our, our mountainous terrain. With that I, I will right up front, this is a cold blooded, absolute rip off of San Antonio. Without them, we'd be about five years behind where we are right now. But they were gracious enough with what they've shared that we've got a pretty good head start. And what we did is we have regional trauma area councils within the state, about 11 of them. We broke the state down where our groups to decide how best to implement this regionally are largely based on those 11 units. Some of them are very urban, some of them are extraordinarily rural. And so with this we're going to have a very different model, I think in terms of the application regionally within the state. But the goal is basically both to maximize our helicopter coverage, much as other people have done in San Antonio has done, to try and provide a little equity in terms of the ability to deliver this product to our more rural clients and then obviously take advantage of what's already been established in terms of an urban model. We are fortunate to have pretty good buy in from the state. The two biggest, I don't know, advantages, but at least the, the things that move the easiest for us is that one vitality. Our blood supplier does 96% of the blood for the state. So the blood supply process I think has been easier for us than it might be for some other parties. And then the other is that at a state level, our scope of practice group that basically advises on that was had enough foresight last year to start piecing together a set of guidelines for when waivers were applied for that those guidelines would already be in place. So it has made the application process for scope of practice waivers very easy. From our standpoint within the state, those two pieces are going well. The flip side of that is I've got 250 agencies and 88 trauma centers from level one to level four, six level ones, almost another 18 level twos. We're pretty dense hospital wise in some areas and then incredibly sparse in others where we've just got critical access hospitals. So trying to piece together a coalition of all parties. And again, I'm just a little piece of that, but brings together a lot of expertise from people both rurally. We have a lot of good legislative people, we've got a lot of good blood banking people. We've got some great level one trauma surgeons and centers to assist with it. So that's, that's moving the right direction. But we are very early in our timeline as we start building this, our timeline, basically, blood collection should be going by later this fall. Starting to stock our hospitals again with the intent that pilot programs would be up and running by about January 1st. The only kicker I will also throw out for you guys, just probably a discussion for another point in the future.