Tranexamic Acid During Prehospital Transport

Are you ready to dive into the latest evidence on trauma care? In our fourth episode of "From Science to the Scene," we break down the STAAMP trial to see if pre-hospital administration of tranexamic acid (TXA) truly improves survival for patients at risk for hemorrhage. While the study found that pre-hospital TXA did not significantly lower the overall 30-day mortality rate, the data revealed critical benefits for specific groups. The results indicate that the Clinician can significantly impact outcomes by providing the medication within one hour of injury or to patients in severe shock. Furthermore, the study confirmed that pre-hospital TXA is safe and does not increase the risk of adverse events like blood clots or seizures. We invite you to explore how these findings might influence your practice or educational curriculum by listening to the full episode and reviewing the research today.

Read the full research paper here: https://jamanetwork.com/journals/jamasurgery/fullarticle/2771225


#NREMT #EMS #EMT #paramedic #research #TXA #medical #healthcare #medicine #study #researcher #ambulance #emergency

Transcript

SPEAKER_00 0:16

Hey everybody, this is Osh Panchel. Thanks for joining today. We're looking at a great study that looks at the operational question of what do we do with a patient at risk for hemorrhage after trauma. Now, the study comes from Frank Gayet and the Stamp Study Group. You gotta have a cool name for a randomized controlled trial. This touch the trial is called transambic acid during pre-hospital transport in patients at risk for hemorrhage after injury. A lot of words, I'm gonna break it down for you, and we're gonna make this real easy. When we all know what's what the problem is, is that trauma is a leading cause of death, and we know that our early interventions can save lives and improve outcomes. One specific intervention that we talk about a lot is TXA. And it's primarily derived from hospital data, and we don't know what the true benefit of pre-hospital TXA is. So in this study, the clinical impact and the safety of administering TXA during the pre-hospital phase of care is evaluated. So the fundamental question was this Does pre-hospital administration of TXA compared to placebo result in lower 30-day mortality in patients at risk for hemorrhage after trauma? So we're again we're focusing on this 30-day mortality window. The study itself is a multi-center trial, double-blinded. That means that neither the participants nor the researchers know which group is gonna receive the actual treatment or the placebo. So now it's could so that's considered placebo controlled because we actually have a placebo and it's randomized to the intervention. So here's the big deal the inclusion criteria for this study is at least one episode of hypotension or tachycardia before hospital arrival. That's gonna be really important as we keep talking about the study. Now, who'd they exclude? They kept everyone from 18 to 90 years old, anyone with a lack of access was thrown out, or anyone who was a who was a prisoner or pregnant. So, how did we actually give them medication? Well, they did sealed drug kits on each ambulance and aircraft, and they randomized by those sealed kits, and they all just had a number. So, and that number matched the number they use at the hospital. So everything was consistent all the way through. So you could have one kit which had your placebo, 10 mils of sterile water, or in another kit, you could have had your one gram of TXA in 20 mils of solution. So all you're seeing is 20 mils of clear fluid. So with that in mind, they wanted to test three specific regimens, which is basically three phases of treatment: the initial bolus, a repeat bolus, and then an infusion. Exactly what would possibly be done in the pre-hospital setting. So again, our groups are gonna be placebo, abbreviated, which is TXA bolus, standard TXA plus a phase, a phase, a second phase placebo, and then an infusion of TXA, and finally repeat dosing, which is TXA TXA, followed by a TXA infusion. So that kind of gives you that framework. I'm gonna come back and we'll continue describing that later. So of course, our primary outcome is that 30-day mortality that I talked to you about. They had a ton of secondary outcomes. They looked at 24-hour and in-hospital mortality, they looked at blood component resuscitation volumes, they looked at multi-organic failure, but most importantly, they started looking at the incidence of coagulopathy and even PEs and DVTs so that we can get an idea of the coagulation problems that you could have with TXA. So let's get right into it. So, first of all, I want you to open up to figure one if you're able to. And in there, they screened 6,500 individuals for this study and they randomized 927. So 461 in the TXA group and 460 in the placebo group. When you look at the TXA groups, our three different key areas: the abbreviated, the standard, and the repeat dosing, they had about 140 to 150 people per group. So pretty well balanced. And when you look at table one of this study, that that's the classic, hey, let's see how similar these groups are. Everything was well balanced. And you expect this. It's a randomized controlled trial. People should be randomized to all the groups and be equally the same across the board. Now, one thing I do want to call out on this table one, and even for you, for those of you who are just listening, the pre-hospital systolic blood pressures were around 126 to 123. So these aren't those horrible hypotensive people. Remember, our inclusion criteria was an episode of hypotension or tachycardia, right? So you could have either. And so they're not super hypotensive. Something to keep in mind as we get to the end of the study. So how did this end up looking? In their figure two, they start talking about survival at 30 days, and survival for the two groups was exactly the same. 8.1 for placebo, 9.9 for our intervention group, no difference between the two groups when it comes to survival at 30 days. What about some of our other pieces, like 24-hour mortality or in-hospital mortality? Guess what? No difference at all between the two groups. So wait, we thought this stuff works. What's the deal? Well, let's go a little deeper into some of the other analyses they did. So let's start with the secondary outcomes. In the secondary outcomes, they looked at 24-hour in-hospital mortality and even the blood volumes. And guess what? These weren't different either. When they looked at no no uh the PEs and DVTs, these didn't increase at all. When you look at the mean blood component transfusion, how much blood people actually get, the mean number, the median number, excuse me, was zero. So more and more, what am I telling you here? There still is no differences until when we start looking at some of the key breakdown subgroups, that's when we things get really interesting. So let's start with mortality risk by dosing. So if you look at the mortality risk, the group with the lowest mortality risk with was the group with repeat dosing of TXA. So if you gave repeat dosing, these people did better. How about if you gave it early? Guess what? These people did better. How about the group with the worst hypotension? Guess what? They also did better. So what does this all mean? If we take everybody who has either hypotension or tachycardia and even one bout of it, there's really no difference in 30-day mortality and there's no increase in thrombotic complications. What does this mean? It means TXA is unbelievably safe. That's the point of the study. It doesn't matter and it's totally safe. That's what I want to hear. But here's the cool part there is truly variability in TXA potential by dosing administration. And also when we do a subgroup analysis, okay, and this is after everything else, when you look at your subgroups, those who were treated within one hour had lower 30-day mortality compared to our placebo. Additionally, those in severe shock who are really hurt, the mortality difference with TXA against placebo was huge. 18.5 to 35% improvement in those with severe shock. So what does this mean? This means that those who are the sickest did get great benefit from using TXA. Now keep in mind, these are smaller groups of the larger study. Keep in mind our inclusion criteria of anyone with hypotension or tachycardia, but this is still a really important finding. Again, big study, it has limitations. The people ain't that sick. And the whole point of that was because they wanted to make sure it's safe. The vital signs weren't that bad, not many people were transfused, and the and they had a low injury severity overall. Now the study was stopped early because of slow enrollment, and so they enrolled about 93% of what they're expecting. I don't think that's a big deal. But in the end, this means the safety of TXA is good, but it didn't let us see the really huge impact of TXA, except in our subgroup analysis. So what's our take home? If we just looked at the high level, no benefit at 30-day mortality. But wait, there's more, right? We gotta look past the abstract. When we look further in, we see repeat dosing is better. We see early dosing is better. We also see that patients with severe shock in the post hoc analyses, TXA had lower 30-day mortality. And when you wrap all this up, it is truly safe for hemorrhage in almost every patient. Well, thanks for joining us, guys. I think this TXA study really gives us an idea of why we're starting to use it so much in the field. So until next time, whether you're hitting the books or hitting the streets, stay safe, stay curious, and keep bringing science to the scene. Thanks.