David Long, MA: Calcium and LTOWB in Trauma (7/12/24)

All right, welcome Everybody. It is July 12th, Friday, and we are joined by several people today that I want to make an introduction to. Our speaker today will be David Long from Tidewater ems. Many of you know David because he's presented on here before and we followed his journey with whole blood. And today he'll be talking about a new research study that they're, that they're launching regarding calcium and the use of calcium with whole blood.

And I'm joined today by Tanner Sumita. So Tanner and I are hosting this webinar and Tanner will be discussing some of that calcium research in a bit. And if Dr. Pepe joins us, I want to.

Here he comes.

I'm going to have Dr. Pepe talk about calcium in a little bit as well. But before we get started, before we get started, I wanted to make an introduction to a few people that I had the very big honor of meeting this week. For many of you who are following on LinkedIn, on Twitter, on the socials, you'll realize that the state of Massachusetts has now approved whole blood for ground ems. And the very first EMS system and hospital system that collaborated to make that happen is Boston Medical center and Canton Fire. So Canton fire is about 30 minutes south of Boston and it's almost, they call it like a medical desert, if you will. So everything kind of streams up towards Boston. And so there's a few people on the call here who, let's say, had the cojones to kind of make this happen. It wasn't an easy thing. So let me introduce the two people. So Leo Reardon. Leo, if you want to say hello and tell everybody who you are and what your role is with Canton, and then I'll move over to Dr. Santo Torres, who is the trauma surgeon at the BMC who made it happen. So, Leo, go ahead, introduce yourself and thanks for joining the webinar today.

Yeah, absolutely. Thanks for having me, Dr. Ranjevi. It's, you know, it's a real pleasure to be part of this. So I'm the EMS coordinator over the Canton Fire Department. So I run all of our ems, you know, the entire division. I'm also one of the architects and authors of our field transfusion paramedic program up in Canton. So, I mean, day to day operations, I'm just overseeing everything that goes on. I was, I was part of the, the team that built that relationship with Boston Medical center to build this program from the ground up. So we're just really, really happy to have this collaboration that we have with BMC and also really proud of the fact that our program has launched and is doing so well with, you know, two for two so far right now with blood transfused and lives saved. So to hell of a good start.

Well, we're all backing you and you know, our goal is for all of us to collaborate and keep in touch with each other. So thanks for joining today. And let's move over to Dr. Santo Torres, who's a fellow Pitt alum. And so he is really a champion for whole blood in the field for ems. So Santo, if you wouldn't mind introducing yourself and saying a couple words.

Absolutely. Thanks, Peter. And thanks for coming out and seeing us. Like I told you before, that it really boosts a lot of the know morale around there because of the, the challenges that we had to go through and continue to go through because of this program. But I was lucky enough to, to team up with Dr. Valkanis, Leo as well. All of us had kind of the same intentions and led to this fortuitous outcome. And so, yeah, so I'm one of the, the trauma surgeons at Boston Medical Center. We're actually the busiest trauma center in New England. So it makes sense that we, you know, we spearheaded this on top of the, the overwhelming efforts from Dr. Balkanis and Leo, who actually were the ones that looked into this initially before I came to Boston. So without, without those two and without our blood bank guys as well, it wouldn't be a program saving lives.

Well, we, we're, we're so excited that you guys joined us today and we're looking forward to the great things you have coming into the future. And then I also wanted to just say a quick hello to Brad Newberry. So Brad and I have gotten to know each other. He's got the largest paramedic program in the country and he teaches people from all over the world. So, Brad, I was very honored to come see your program, your platform. You wouldn't mind saying a couple of words and I'm going to have you come on one of our webinars and talk about all you do around the world with disaster and also training. So you want. Who wouldn't mind saying a couple words? Brad?

Sure.

Thank you very much. You know, first, I am the biggest Canton Fire cheerleader on this. I'm a true stakeholder. And not only do I live in the area, but I'm a captain paramedic with the neighboring department. So when, when Ken was going to do this, we were all in. We know the value of it. I've seen the literature. And we became huge Champions and anything that we could do, you know, not only from our department, but also from our school, we have a pretty large platform. I don't know if we're the biggest. Pete, I don't know how you measure those things, but. But we are. We do have a large.

Education program. And I think if we can partner with Canton in that to make sure and all of you to make sure that that's. That the message is being put out there, we do have a good, a good platform for that and I think that'll be important moving forward. And you know, thank you so much for the invite. Truly a pleasure to have you come and visit our school. And I was so excited to be part of that discussion in Canton. Thank you, everyone.

Thank you, Brad. I appreciate you so much. So what I want to do next is I want to bring in Dr. Pepe. So Dr. Pepe has recorded several presentations on calcium and I wanted him to give a little bit of a primer just a couple minutes before we move on to David. Regarding. So Dr. Pepe, are you able to join us? Are you here to join us to talk just a little bit about calcium? Why it's important before we move on to David's presentation.

So first of all, I was just up with folks, actually worked with some of the folks near Canton Fire when I was up in Mansfield a few about a week or two ago. And then of course I wish I had come seen Dr. Torres at the Boston Medical Center. I was out with Sophie Dyer and we were doing the Boston Pops thing. And so just I'll have to regroup with you sometimes and all of you up there. So thanks for the great work you are doing. We're really pleased.

Right.

To launch into what Peter wants me to do is that first of all, I'm blinded to what David Long is going to talk about. But I'm sure it's going to be great. But the quick background is that everybody's pretty much sold on doing the blood and blood products. And I'll tell you more about in the future about what we also need to do next steps along those lines. But one of the things I'm you could definitely do in the meantime for patients who have pretty good signs of being in a hemorrhagic state is to look at both TXA and calcium. I think the TXA thing, we've gotten it pretty straightened out now because we know that if you give it early, it's great. You give it even an hour later, it could be starting to have more complications than it has a benefit, the risk for benefit ratio. Flip. So we, that's, that's. We could come back and talk about that at later time. The calcium is a very interesting thing. It's very clear cut that calcium is needed. When you're giving blood products that have things like EDTA and other citrates that will suck up calcium. We. It does that on purpose because so to keep it so that you can, it doesn't clot and you can transfuse it in there, but once you put it into the human body, it will suck up also additional calcium there and you can become significantly, I would even say hypocalcemic. So restoring calcium becomes kind of important in that situation. I think most of us are now just automatically doing it. There's some pluses and minuses to whether we should give calcium chloride or give classic calcium gluconate. There's different factions that really are set in on different things and we're still learning a little bit more about that. I think most people are giving calcium chloride, but there's some caveats. The lastly is that I want to bring up is that there is actually a hypocalcemia associated with trauma alone, which few people have been able to describe why it happens or even sometimes even document that it's happening. But I believe it does happen and it has probably to do with ions when your hydrogen ions are going up and they will go up when you. For example, hemoglobin itself is a great buffer, but for other reasons, such as developing lactic acidosis. And they may compete and then shove calcium into the system cells. So the question is then also is that then if you do give calcium, then do you cause problems with other ions and whether it's potassium or whether it's phosphate, et cetera. So we're learning a whole lot about it. It's a great field. So we're really glad to present that today.

Just to give everyone an idea, we in Palm beach county just finished a protocol. We just kind of. The ink is still wet, but we are doing a gram of calcium chloride in a 50 bag of saline, 60 drops set wide open so that we mitigate the extravagation issues. We're not going to just be pushing it right out of the brista jet. So just so that that's coming with us. But let's move into.

Peter, may I interrupt? Peter, that's. It's an important point is that just when you're giving blood alone. So I'm just, I'm taking it to the next level that we may have other reasons to give it. Yeah.

Okay.

When you're giving blood.

Absolutely.

I think all of us agree. Let's do it. Okay.

So. Yep. Yep. Okay. So thanks, Paul. So, David, if you wouldn't mind sharing your screen and we'll love to see your presentation regarding if you want to set it up for us as to what, how this research project is structured and what you're aiming to find. And then we're going to, you know, get into a little bit of literature review with Tanner and then we'll open it up to everybody else.

So just a quick setup. I mean, it really is about.

The people that are on this webinar. You know, again, I have learned so much from you folks essentially from, you know, early 2022 to now. Feel like I've been drinking out of the proverbial fire hose. And it's always great that there are play trailblazers out in front and being able to kind of, you know, see things and, and learn and, you know, then even postulate new questions. And that's kind of where we were particularly, you know, after, you know, spending time with Tom Dransfield and Meg, you know, with New Orleans and what they were doing with the advanced resuscitated care bundle. We were happy to be following in their footsteps. So we do a lot of collaboration and there are some unique differences to our respective programs. So we do 2 grams of TXA, a unit of whole blood, and then a gram of calcium gluconate versus they do the 2 PAC cells plus 2 of TXA and 2 of calcium chloride. And for us, the decision to go with calcium gluconate was just a patient safety, you know, discussion. You know, we checked with our local healthcare systems. Nobody was given calcium chloride outside of a central line. So as we kind of talked about that with, you know, the, again, patient safety advocates, you know, we, we felt like it was the, the right thing to do is to, to move into that safer direction. But what we couldn't find in any of the research is what, what did the calcium chloride or calcium gluconate do in regards to how much did it move, you know, ionized or serum calcium levels, you know, in our, in the affected patients. So.

This will just walk through this, Pete, real quick, try to keep this till three to five minutes. But essentially overarching, you know, question for us is, you know, what, what's going on with calcium when we're doing blood transfusions, you know, and trauma from a pre hospital perspective. So this is obviously led by Sentara Health in, in the region. We're collaborating, you know, as a regional EMS council and the ones that are, you know, essentially.

Overseeing the whole blood program, you know, in region. So I'll just, you know, go ahead and move this. So it's a retrospective comparative analysis of the impact of pre hospital, you know, blood transfusions and what that does to calcium levels and specifically what, what happens, you know, to our patients.

We identified there was little research on the impact of pre hospital blood administration on calcium levels. So it gave us an opportunity to, you know, know, take a look. Specifically, what we're, what we're going after is the impact of pre hospital blood administration on calcium levels.

What the impact of prehospital blood administration does on patient mortality and overall outcomes. And then, you know, our blood administration as it relates to blood product administration and calcium replacement and trauma patients. So I'll pause here real quick just to say so in a matter of a couple of months, we'll actually have a, a second almost parallel IRB that is actually looking at the same data elements, but now it will actually incorporate our advanced resuscitative care bundle so we can pay attention to the patients that are getting the TXA and the calcium gluconate that allow us to do essentially comparative studies. All right, so background and significance. I won't spend a lot of time here because Dr. Pepe already did and I think Dr. Tanner will probably, you know, address this. But we were certainly looking at, you know.

From a background and significant standpoint, disruption of calcium levels. We know, you know, effects on coagulation, muscle contractility, cardiac contractility. So.

It'S one thing for calcium to be consumed as a result of the trauma, but then to make it worse when we start transfusion, as Dr. Pepe said, when we're adding in the, the calcium citrate, you know, sodium citrate as a chelating agent. And then, you know, there's more research that's being done regarding hypocalcemia and, and what ongoing effects that it has in the body's response, even in the context I think you'll see here on the next slide, we talk about moving our conversation from the lethal triad to the, to the death diamond as a result. So we look specifically at these three areas from our lit review perspective. What's going on with trauma and calcium, what's going on with blood transfusion and calcium. And then what, what's going on, you know, with calcium and mortality. And you, you can see that, you know, all of calcium is linked to all the components of the lethal triad. So you figure that that.

Isn'T an accident and something that we should be paying attention to. You can see in a randomized controlled trial, 160 trauma patients receiving pre hospital plasma, you know, were identified to be, you know, hypocalcemic after receiving, you know, pre hospital plasma. So a pretty big significant, you know, jump, you know, in what we're seeing as, you know, impacting patients, you know, with these transfusions. And then, you know, we're looking specifically at the mortality levels here, right? So we see that patients are worse with trauma induced coagulopathy, you know, as a result. So to combat that, right. How do we, how do we do that? And so calcium chloride or calcium gluconate obviously, are the two, two methods by which we get there. So the study basically aims, you know, to look at trauma patients, you know.

That are coming into the ED and look at their mortality rates. And then the, the retrospective chart review will allow us to start getting an idea, you know, and specifically in our data set, we're looking at what both serum and ionized calcium levels are on a mission into the ED at 24 hours, 48 hours, and then on admission, and then they will actually also be evaluating what their calcium levels are at discharge and our final, final disposition. So we have a set of inclusion criteria, right? 18 years of age, you know, to 90 unit of blood administered. We don't do PAC cells, but we're looking at all trauma patients from a number of systems. And then we're looking at that first 48, you know, our.

48 hours of hospital stay, right, since we know that we have some patients that will come in and they won't make it past 24 hours. So we're excluding those arrests, as you can see here in our exclusion criteria. So we're excluding less than 18 years of age, cardiac arrest prior to arrival, cardiac arrest and death prior to blood draw and et cetera. So not going to read these to you, but essentially what we're looking at here is where we're going is trying to look at both ionized and serum calcium levels. We have the capability to do these draws and analysis at every step within the hospitals. So it can be done in the ed, it can be done up in the ors, it can be done at the icu.

But you'll see the ranges here for both ionized and serum as normal, what's considered low. And then from a critical low perspective, and for us, just in a preliminary, you know, review, we're seeing 3.5 to 4 for the majority of our trauma patients. So you can see that that puts us in that low to almost critical low range, you know, of calcium levels, you know, in our patients. You know.

How many patients was that, David?

Total?

Like that preliminary number. What's the end on that?

You know, doc, I don't have that number. I'll get it for you. I know that we're reviewing a total of like 18,000 charts, so let me. Let me get back to you on that actual number. So I don't. So I don't fudge that.

Right.

One other question that we were asked is, you know, again, this whole issue of serum versus ionized. And, you know, our focus is on the ionized calcium level. And primarily that's due to, you know, it being the. The free calcium and the most active form, you know, calcium in the body. So we think that's the thing that makes the difference, if you will. So. And then there's a set of references in case anybody's interested. But we're, we're excited about that. We finally have this moving and we're excited to, you know, get to a point to where we can really call the data and then get to the point of publishing.

All right, that's great, David. Great overview. And I definitely want to get some conversation and I want to bring in Dr. Torres in a second, but let me bring in Tanner. Tanner, you're our research brain here.

Can you talk to us about.

What the past is and then also about what David's study is looking at to make some comments on that?

Sure, absolutely. And so I think some great context was provided definitely by Dr. Pepe and Dr. Long and the risks of hypocalcemia in this population of patients certainly been well summarized.

I'm sorry, no, doctor, just a paramedic.

Sorry.

Paramedic.

Long.

Sorry.

And so I think from a kind of a thousand foot view as a field, I think the question that we all want the answer to is does administration of pre hospital hypocalcium as part of a bundle of care alone with blood, does this actually provide a mortality benefit to trauma patients? But I think, you know, before we get to that big randomized controlled trial that's actually going to answer that question, there's a bunch of other questions that need to be answered. I think we need that we need to answer the question, you know, who is actually at risk of hypocalcemia? So, you know, is that. Is there some sort of marker for who actually is going to have low calcium if you don't have kind of point of care labs available? Can we use vital signs, patterns of injury? Does transport time play a role? I think those are all kind of open questions. And we also need to, you know, what, what formulation of calcium should we be giving? The chloride, the gluconate, when should we be giving it? Right? Just pre hospitally in general, for, for a subset of patients with a certain injury severity, is it after the first unit, second unit, etc. And so, you know, again, we've discussed risks, right? Of course, calcium gets consumed during the coagulation cascade, right? We lose it onto the ground. There's the potential of intracellular shifts, it can be chelated by lactate, we can get citrate toxicity. And so it seems that to kind of promote hemostasis, it seems like a good idea to perhaps just empirically administer calcium to all bleeding trauma patients. But just to play devil's advocate a little bit, I wanted to highlight a couple of potential risks of calcium administration. And admittedly, most of these are purely theoretical. So first of all, you know, we know that, that calcium provides some hemodynamic benefits. It specifically can improve cardiac contractility. I know in kind of the pediatric setting, especially in the icu, it's used almost as sort of a vasopressor. And so through the lens of hemostatic resuscitation.

Administering an agent to a bleeding trauma patient, that can basically increase shear stress on the vasculature, increase mean arterial pressure, increase cardiac contractility, maybe there's the potential that we can kind of pop clots and worsen bleeding. There's also some suggestion. Many exsanguinating trauma patients are polytrauma patients that also have concomitant traumatic brain injury. And calcium excitotoxicity is kind of part of the pathophysiology of brain injury and secondary injury following tbi. Additionally, and this is kind of, it's just observational data, but there was a recent study published out of Germany, out of a large trauma registry that actually showed that hypercalcemia was also associated with increased mortality in addition to hypocalcemia. And so maybe there's some risk in trauma patients of just empirically administering calcium to everybody who's experienced experiencing bleeding.

In addition, so, so when it comes to kind of the, the hemodynamic part of the picture, I'm very interested in pre hospital vital signs. One thing I wanted to highlight is it's the potential for citrate toxicity may be increased in a subset of patients that have hemodynamic compromise. So if you have less blood flow to your liver, for instance, you may be more susceptible to citrate toxicity and you may want to administer kind of calcium more liberally in those patients at a higher dose or earlier. And so that's kind of the summary that I have. I also had one question for you, Mr. Long. In terms of the cut points that you have for this study in the literature, there's a couple really great reviews that have been published in the last two or three years. And almost all the studies previously have looked at cut points of less than 1 millimole per liter, less than 0.9. Those are the thresholds for hypocalcemia using ionized calcium. So I'm just wondering how your cut points match up with those. If you kind of derive them from internal data, just kind of where those cut points came from.

Cut points were essentially following what we were seeing, you know, in research and literature now. So I think that's another thing, you know, to discuss. So what I presented, you know, was milligrams per deciliter versus millimole. So sometimes, you know, people get, I guess, anxious, maybe the right descriptor, you know, for that. But.

But those were the established cut points, you know, from their lit reviews.

Okay. All right, excellent. So let me bring in Dr. Pepe's at his hand raised. So Paul, you go. And then I want to bring in Dr. Torres. Go ahead, Paul.

Yeah, yeah, because you know, I got to start another meeting in two minutes. So just real quick, I just want. First of all, this is great, especially at your collecting all the data in terms of the actual levels and so on. One thing I just. Two or three things, just based on experience from my days in critical care is I know when you're giving calcium, it'll actually then, you know, lower phosphate levels. You know, when you're doing so there's things like that that'll go on or we give calcium the lower potassium. So it would be great to know all the other things. It's not just, you know, me, I'm totally anti. I'm not a binary person. I think in a multi dimensional. That's my problem, you know, I think multi dimensionally there's so many other effects. So I don't know if you're capturing those. That's number one. And by the way, so this is fantastic that you're doing this. And then especially if, as Tanner was referring to, we're looking at both not only people getting blood, but those who are just having, you know, a hemorrhagic State, et cetera. All right, then the second thing I want to make a point on this is one of my little like area that I like to harp on is that when we come to a. Patients who are pulseless in those situations, they have a very, you know, very small chance of coming back when we arrive on scene and they're pulseless. But I like to always distinguish that there are people who are not necessarily in cardiac arrest. They're in circulatory rest, whether because they have an empty heart, because there's no because their preload's gone, or whether they have a pericardial tamponade or retention pneumothorax. And now they are not in cardiac arrest necessarily. The heart is still beating. And so they will be in cardiac arrest in about five or 10 minutes, if not sooner. But I like to always distinguish that. So I always like to approach those patients as the patients who we arrive who are pulseless and then we have to discern are they really got a cardiac arrest. Like in our area, we're thinking about doing ultrasound to see if the heart is actually beating under those circumstances. So just for everybody, I like to use a terminology, post traumatic circulatory arrest or pulselessness as a distinguisher. So we can understand that because those. Because a few minutes there you might be salvageable.

Okay, that's a great. That's a great point. Great point. Awesome. Let me bring in Dr. Thanks, Paul, and we'll be right over to yours in a second. But.

It'S one of my favorite topics, so thank you very much. Thanks, Dave. Bringing us to the next level.

Okay, thanks, Paul. And then Dr. Torres, you.

You are. You guys. So it's good. Okay, see you later.

Dr. Torres, you're a practicing surgeon and you're a researcher specifically with. As it comes to blood admin, what are your thoughts on this topic?

I think this is great, David, you know, great presentation and again, thanks for letting me come into this meeting and also provide some comments. It seems like you do have the rationale and the evidence there to support something like this. And I do believe it's something that we really need to look at. I think there's definitely a need for this. So.

So is there a. Do you guys have a specific. Any other specific pre hospital criteria on. Because I know this is all retrospective that you guys are looking at on your Semper population. Are you looking at specific patients at risk of hemorrhage? And how do you define that? Is it by vitals, et cetera?

So with this particular study we narrowed the focus to only look at trauma hemorrhagic shock. And we are, we are doing both blunt and penetrating, but we have excluded, you know, looks at our hemorrhagic shocks from like medical etiology.

So. Right. So is there a. And you may not know this off the top of your head, but do you guys have a definition what is considered, you know, traumatic or hemorrhagic shock?

So we're using essentially our transfusion criteria, predominantly shock index. We're using, and we have probably a little bit more conservative shock index than most. We're, we're at 1.2. And the criteria, you know, for us, especially a penetrating trauma, you know, we use that criteria. We also, you know, are also, we're not using that exclusively. I think Dr. Pepe once described before that we could miss patients, you know, on shock index alone just because of other, you know, underlying medical conditions, medications that might, you know, be consumed and et cetera. You look at, we do look at blood pressures, we do look at heart rates and things like that.

Picture. And I agree with, I mean, doctor, Dr. Pippa is just so brilliant. I've been following him for some time now. And, but, but at the same time, you know, with, with the shock index and I like using shock index as well with the shock index also, is that it may also overestimate patients and over triage in patients. And so you may be giving this, you know, calcium to patients who may have done well otherwise. So I think, I think it makes sense including shock index. But I will also, you know, if you guys have been planning on doing this, looking at subgroups alone of shock index in addition to what their blood pressure is like as well, you know, because you can have a shock index, you know, blood pressure 1, you know, 100 and then, and you know, a rate of 110. And you know, your, your shock index is going to be high. So it makes sense if you look at a shock index and in the subgroup of shock index and who also has a blood pressure less than 90, for instance, look at the degree, because just a current study that I'm working on now in terms of whole blood, I'm, you know, looking at that there, there are degrees of mortality benefit based on blood pressure alone in addition to looking at shock index.

So, so let me, let me, let me interrupt real quick and say, doc, you got a couple of seconds for me to do another screen share?

Yeah, absolutely. Yeah, yeah, let's do it.

So I think to your point, Doc, this is the thing that we have prepped and are coming after. So I think what you're talking about, your focal areas, this is where we're going to do that. So this first retrospective look is just what's happening with calcium in our trauma patients and particularly with administration of whole blood. But this next one we'll actually look at while we're administering TXA and calcium, you know, factoring in, you know, trauma and et cetera. So that when you, when you come down here into the primary areas, what's the impact that the arc bundle administration has on calcium levels and trauma patients, on administrations, you know, through MTP activation, you know, so on and so forth. So it's a, it's the follow up study, I think that's going to be more focused on the things that you're describing.

I see the, the other thing is.

So your data source. I'm not, don't want to, I'm not trying to ask for the specifics. I hear that it's all retrospective. 18,000 patients. Is this kind of in one part of the country? Is it just at your center? In terms of the data itself, this.

Is in the southeastern portion of Virginia. So we are basically a 10 jurisdiction, probably looking at a population of 1.5 million across. I've got 14 facilities, four current trauma centers, you know, in region, coming from, from this area.

Okay.

Now the other part of that is also to recognize we're doing this essentially in parallel, if you will. New Orleans EMS and LSU is doing very similar study and evaluation. We've shared our data collection tools and are collaborating because our patient populations as far as young males penetrating trauma look a lot the same. We both are doing, you know, a resuscitative care bundle of some type. And I see Tom's on the call, so Tom can also speak to this. And then we just recently reached out and are working with some folks in Birmingham, Alabama who's also now coming online to do another, you know, parallel study. So we'll have three different groups actually doing things in these respective areas of the country that we'll be able to point at.

Okay. And the reason why I asked that, because I know, and you guys may be aware of this as well. Right now there's an active multi center RCT double blinded, the Cavalier trial. And so they're looking at pre hospital calcium in patients at risk of hemorrhage.

And then in hospital vasopressin. And so, and the thought is, you know, you know, I guess with the vasopressin piece kind of builds on the RCT that Carrie Sims had done at Penn, where there was a decrease in the amount of blood product needs or volume. So. So the connection here is that, you know, are you guys looking at.

Since. Since this trial is again, somewhat new part of your.

I guess, regression modeling when you're doing these statistics, are we. Are we accounted for patients who are getting empirically vasopressin in the ed? Because that can obviously is associated with the treatment, but also may be associated with the outcome as well.

I will admit that one I can't answer, but I will dive into that just to verify with Dr. Gordon.

But now I think. I think this is really great, though. I'll be interested in what the outcomes look like.

And I think what we can do is because we have New Orleans. Who's on the call? So, Tom, are you on the call? Would you mind just talking quickly about what you guys are doing with Cal because you've been putting some articles here in the, in the, in the chat.

Yeah, I included or added Duchesne to this. I don't know if he's on. Juan, are you on?

Yes, sir. Yes, sir, I'm here.

Oh, there he is. Oh, okay.

Hey, my name. So, yeah, let him speak on it because he's the one doing all the studies. But we've been using it since 21 and we had it with our blood bundle and arc bundle, like David was saying.

So.

And just about every one of ours gets it.

So.

So because we're using PRBCs, of course, we're not using whole.

So that arc bundle. So it's a bundle of calcium txa. And was it something else? And, and yes, we.

We do.

2. 2 and 2. 2 units of PRBCs, 2 of calcium, 2 grams of calcium, 2 of TXA.

Right.

So. So in their case, because the load of EDTA is so much higher, it makes sense to get the 2 of calcium in. 2 of calcium chloride and. But 1 or time. You guys don't have any early data, do you, yet on the initial calcium in the ed?

No, that's. Yeah, that's something that we're looking at. And first of all, David, great job. I'm looking forward to see your outcomes. I know you've been spearheading heavily on your area and Chris Santo virtually meeting you. Nice to meet you.

Yeah, hey, I'm starstruck here with all these giant in trauma surgery, so not great to meet you.

Yeah, nice to meet you, man. No, I just wanted to say very quickly that the necessity for calcium replacement. We're doing chloride just because we. We have a thinking process that actually will be into the system faster as real ionized calcium rather than through the kinetics of the liver with gluconate. But that's just. There's no evidence behind it right now we're going to start looking at that. We are basically 250 place patients plus right now. So I'm going to be looking at that data. The other thing I wanted to quickly mention, I think that David is gonna. If David, if you have an open registry or something like that that you guys want us to put some information to your data, let me know. Because this hypocalcemia is is a pre is prevalent in 56% of the patients with hemorrhagic shock. Not only that, those patients are basically five time likelihood risk of having coagulopathy. So that's why this combo of potential txa, now pcc, that is going to be a very good interesting study coming up soon in, in that pre hospital arena. It's going to give us a great information, a lot of information that, that we don't know yet what it's going to look like in when they arrive to us.

All right, this is fascinating. And so that actual concept that you just said that the ionized calcium is just readily available at the moment. It goes into the vein as opposed to gluconate. That's important. So just to clarify for everybody, the gluconate versus chloride, it's essentially a safety measure. Getting it in so it doesn't extravagate and cause damage is diluting it like we're doing at Palm beach now putting to a 50 bag. Would that mitigate the majority of the of the issues that you see with calcium chloride? Juan?

Diluting it.

Diluting.

Can potentially, it can potentially definitely make a difference to be frank. Honest Peter, we haven't had a single AE on on chloride in the pre hospital and in follow up in the, in, in the hospital. I know that there are some occurrences in the pediatric service pre hospital but that I mean once they're in the hospital I'll be frank, honest. It's not unusual to use gluconate but for chloride it's just so much faster.

Just to give it as a push.

Gotcha. One of these studies and I know that Santo just mentioned as an RCT coming out like when, when do you think we're going to have some pre hospital into hospital data? Is it this year? Do you think it's going to be ready? Does anyone have any idea when these studies are?

It's going to be a Hot second.

Yeah, it's going to be. They just. So, at least for the Cavalier trial, they just started enrolling last year and they, and so they need 10, excuse me, a little over a thousand patients. So it's going to be, it's going to be some time. Now.

I did want to just. I had a quick question because you guys said you guys get 2, 2 and 2. Were there any thoughts of looking at, you know, the subgroup of, you know, maybe, you know, two ver. Two grams of calcium versus one gram, similar to like the, the TXA stuff, you know, because of txa, maybe the, the higher bullets because you're saturating more of the receptors and that may be related to the, the, the outcome difference versus the, the lower. Have you guys considered that at all?

You know, I will let Tom know because he may know better the compliance on curve on, on calcium, but I believe that most of our patients are getting, I think the compliance is close to 90 for calcium, if I'm not mistaken. But I will let Tom get into that.

Yeah, that sounds about right where we are now. If they don't, we obviously, obviously the emphasis is on the blood. So if they only have time to get the blood on board. They do, then the calcium's next. TXA is what we call lanyap down here. So that's just the little something special. Right. And that's. Sometimes they get it, but I'd say like probably 80 to 90% of the time they're getting the full bundle, so.

Right.

And here, here in Palm beach, we're only going to, we're going to come out with one gram. So we're going to have data here as well moving forward. So it'll be interesting to see. And of course, we're sending all of our data to the registry, to one registry, the Spark Registry. So this, this really makes it much more important for everyone who's starting a blood program to submit their data to the registry and so we can actually look at these types of cases and make better decisions. So just to finish up, am I hearing this correctly? Because there's a lot of people on the call who have a program or starting a program or thinking about starting a program. Are we in agreement then that some sort of calcium should be given after the whole blood or the prbt? Is there anyone saying that we shouldn't and we should be waiting for the data to come out? Let me go with Dr. Duchesnian and Dr. Torreg. Are you up or down on calcium for everybody?

I'm totally. I'm totally up on the. I'm totally up on the calcium. Just because the things that are. That are out.

I, I agree with my compadre. And that's a selection bias on your two first.

Clinical and academic trauma surgeons. I think we're going to be listening to you guys. So that's what we wanted to hear. Is there anybody on the call who has something that, like a reason that you wouldn't. Would not give chaos them? Obviously we don't have all the data to our advantage here. We do have some information that has been published that we've seen and that want to put into the chat. But that's why we made the decision to move ahead and go forward with it. We don't see any downsides to it, especially with just one grand that we're getting. So we look forward to. Yeah, go ahead. Who wanted to make a comment?

I. I have one final question, doc. You know, because right now I think if we look at what we're doing in Tidewater, what Tom's doing in New Orleans and what you. Charlie's doing down where you are, right?

It.

I think there's three programs that are uniquely tweaked, right? So Tom's doing 2, 2 and 2. I'm doing 2, 1 and 1, where I'm doing 2 grams of TXA unit whole blood and a gram of calcium gluconate. But I thought that there was information from you that you guys were given two units of whole blood. Is that, Is that correct?

We, we have, we have about 11 or 12 patients thus far out of the 120 that have received two units. Now, all of those patients have lived, but I'm not sure what that means. They could have lived with one unit too. I don't know. But, but we, we. We are now moving to one of calcium. The protocol is written. We just got to get it out into the field and launch that. But. So you're right, there are three. At least on this group, there's three different ways. I see the Canton folks. So Leo just said that they're doing one, one and one. A gram of. Sorry, a unit of blood of whole blood, a gram of calcium gluconate and a gram of txa. So that's, that's kind of a one. One on one symmetry. For what. Actually, they're doing only a gram of dxa. It's interesting.

I'm trying to get. I'm trying to get them to, to do 2 grams. I recently had the hospital here change the practice that by default we should be giving these patients 2 grams. So we're working on that in the pre hospital space.

And the reason that we're doing that too, Doc, is simply just because mass OEMs protocols limits us to one gram of TXA at this time.

Gotcha.

So our group, obviously, with Dr. Torres leading that, we've been discussing the idea of just submitting that as part of our special project waiver to just bump that up to 2 grams of TXA.

Right. The folks like us who are in a delegated practice state don't have to worry about those things when you have to worry about the other people in the state. I get it. So that makes perfect sense. All right, well, David, I'm going to give you the last word. You gave us a lot to think about. The discussion went longer than any other webinar we've ever had. So thank you for doing that. Give us your final word and take us away.

Well, again, I think I am not the quality of researcher that somebody like Dr. Duchesne or Mr. Torres. Dr. Torres is. But, but I, I am passionate about, you know, this initiative and effort to, you know, move the needle on what we're doing in trauma care. So I think what's been going on since 2017 in the country is absolutely fantastic. And we should quickly be setting a pathway for anybody else that comes aboard, you know, to quickly ramp this up and start making those kind of impacts. So we shouldn't be losing anybody else, especially when we have a solution. So thanks.

Well, a hat tip to people like you who are actually not just doing the work, but actually publishing, looking at research, ideas, concepts, and then letting the rest of us know that's the way this should be done. The fact that we have support by amazing trauma surgeons on the hospital side, this is a very great place that we're all in. So thanks everybody. Great conversation. I have a feeling this is going to convert a lot of people to modifying their thought process and even their protocol in the future. So happy Friday. Have a great weekend. I put the webinar link for Dr. Pepe in the chat, so feel free to pop over there. We're going to be more whole blood conversation there with the new CMS rule that is now going to be allowing for ALS2 billing if whole blood is given. And I encourage everybody to go into the, into the open public comments and say that it should be more than whole blood. It should be every blood product that you get an ALS2 level billing. And then in the future they'll go into maybe other types of payments. So this is kind of a step one. And I know that several people on this call have been involved with that. So I know that several people will be talking about in the next webinar. So we'll see you on the other side. Have a great day, everybody. Thank you.

Thanks, Doc.

Thank you, guys. Appreciate you.