Category Archives: Resuscitation

Resuscitation

REBOA For Pelvic Fractures

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Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is one of the newer shiny toys that trauma professionals have adopted over the past 8 years or so. It is used to buy time for a patient who is near arrest in order to temporarily stop bleeding and get them to the operating room.

And as with all new toys, everyone wants one! I have always advised caution. Adopt a data-based approach to toy usage. Unfortunately information has been accumulating ever so slowly on this one. To help remedy this, the AAST created a registry in 2013 to consolidate the low REBOA experience numbers accruing across the US.

A group of seven surgeons representing higher-volume REBOA centers collaborated to review the AAST AORTA registry, which prospectively collects data on patients who undergo aortic occlusion. They retrospectively reviewed over six years of data on adult patients receiving REBOA for pelvic injury. They examined demographic, procedural, and outcome data in patients who underwent this procedure, both with and without other interventions like preperitoneal packing, angioembolization, or external fixation. For inclusion in the study, patients needed to have sustained blunt trauma and survived beyond the emergency department.

Here are the factoids:

  • Of the 207 patients with pelvic (Zone 3) REBOA in the registry, only 160 met inclusion criteria
  • Patients who only had REBOA suffered a mortality rate of 40% (5% in OR and 35% in the ICU)
  • Patients who had REBOA plus one of the other interventions had a 31% mortality rate (6% in OR and 25% in ICU)
  • Patients who had REBOA plus two other interventions also had a 31% mortality rate (12% in OR and 30% in the ICU)
  • Adding external fixation with or without another adjunct appeared to decrease mortality by half (from 50% to about 25%)
  • Complications were very common in all subsets, ranging from 35% to 86%
  • Patients receiving more interventions typically were more severely injured
  • No combination of REBOA and adjuncts was superior, but addition of an external fixator did appear to improve survival
  • Patients receiving angiographic embolization had a higher incidence of AKI, sometimes resulting in the need for dialysis
  • There were no significant outcome differences with REBOA use alone or with additional adjuncts

Bottom line: This was a primarily a descriptive study of how REBOA is integrated into pelvic fracture care at select US trauma centers. It was not really designed to compare the efficacy of REBOA vs preperitoneal packing vs angioembolization vs external fixation of the pelvis.

But it does show that survival remains dismal in these patients and the complication rates of REBOA + adjunct use are considerable. The authors correctly conclude that REBOA is being used in the treatment of pelvic fractures, frequently with the addition of other adjuncts. They state that the benefit of more interventions must be balanced against the potential for complications. And finally, they note that there is a need to fill in the evidence base if we are ever to adopt REBOA as a standard of care for select pelvic fractures.

What does this mean to all of you who are thinking of playing with this toy? Proceed with caution! The learning curve is steep. The complication rate is high. The opportunity for mayhem is great. This means that you must proceed deliberately. Get some advanced training with this technique. Use your performance improvement program to impartially critique its use with every deployment. And submit your experience to the national registry so we can all learn from your experience and figure out how to optimize use of this tool.

Reference: Patterns and outcomes of zone 3 REBOA use in the management of severe pelvic fractures: Results from the AAST Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery database. J Trauma 90(4):659-665, 2021.

 

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Prehospital, Resuscitation

Best Of EAST #16: More On TXA

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Here’s another abstract dealing with TXA. But this one deals with the classic CRASH-2 use for patients with major bleeding. The original patient showed that TXA improves survival if given within 3 hours of injury. More and more prehospital units (particularly aeromedical services) have been administering TXA enroute to the trauma center to ensure that this drug is given as early as possible.

Many of these same services carry packed cells (or in rare cases, whole blood) so that proper resuscitation can be started while enroute as well. A multicenter group led by the University of Pittsburgh evaluated the utility of giving both TXA and blood during prehospital transport.

Their study summarizes some of the results of the Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial). This study ran from 2015 to 2019 and randomized patients to receive either TXA or placebo during air or ground transport to a trauma center. It included blunt or penetrating patients at risk for hemorrhage within 2 hours of injury who were either hypotensive or tachycardic. Outcome measures included 30-day mortality, 24-hour mortality, and a host of complications.

This abstract outlines a secondary analysis that retrospectively reviewed the impact of using prehospital packed red cells (pRBC) in addition to the TXA/placebo during transport. 

Here are the factoids:

  • There were 763 patients in total, broken down as follows
    • TXA only – 350
    • pRBC only – 35
    • TXA + pRBC – 22
    • Neither – 356
  • Patients who received blood with or without TXA were more severely injured with ISS 22 vs 10-12 in the non-pRBC groups
  • Mortality was higher in the pRBC (23%) and TXA+pRBC groups (29%)
  • TXA alone did not decrease mortality
  • TXA + pRBC resulted in a 46% reduction in 30-day mortality but not at 24 hours
  • packed cells alone decreased 24-hour mortality by 47%

The authors concluded basically what was stated in the results: short term mortality was decreased by pRBC alone, and 30-day mortality with TXA + pRBC. They recommended further work to elucidate the mechanisms involved.

Bottom line: This abstract may also suffer from the “low numbers” syndrome I’ve written about so many times before. The conclusions are based on two small groups that make up only 7% of the entire study group. And these are the two groups with more than double the ISS of the rest of the patients. The authors used some sophisticated statistics to test their hypotheses, and they will need to explain how and why they are appropriate for this analysis. Nevertheless, the mortalities in the blood groups number only in the single digits, so I worry about these statistics.

Here are my questions for the authors and presenter:

  • How do you reconcile the significantly higher ISS in the two (very small) groups who got blood? How might this skew your conclusions regarding mortality? Couldn’t the TXA just be superfluous?
  • How confident are you with the statistical analysis? Could the results be a sampling error given that red cells were given to only 7% of the overall study group?
  • I am having a difficult time understanding the conclusion that mortality was reduced in the blood groups. Specifically, it is stated that 24-hour mortality is reduced by 47% in the blood-only group.  But the mortality is 14% (5 patients)! Reduced 47% from what? I don’t see any other numbers to compare with in the table. Confusing!

Obviously, there must be more information that was not listed in the abstract. Can’t wait to see it!

Reference: PREHOSPITAL SYNERGY: TRANEXAMIC ACID AND BLOOD TRANSFUSION IN PATIENTS AT RISK FOR HEMORRHAGE. EAST 35th ASA, oral abstract #39.

 

 

Reference: PREHOSPITAL SYNERGY: TRANEXAMIC ACID AND BLOOD TRANSFUSION IN PATIENTS AT RISK FOR HEMORRHAGE. EAST 35th ASA, oral abstract #39.

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Head, Resuscitation

Best Of EAST #15: Prehospital TXA

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The world is divided into trauma centers that are TXA believers and those that are TXA nonbelievers. It all depends on how one interprets the CRASH-2 data and subsequent studies. Then came CRASH-3 with TXA use for patients with TBI. This large study found improved survival in patients with mild to moderate head injury when given “early.”

The group at Oregon Health Science University tried to better define this concept of “early.” They examined early vs later administration of TXA in patients with moderate to severe TBI. Note that this degree of head injury is a bit different than CRASH-3 (mild to moderate in CRASH-3 and moderate to severe in this one). This was a multicenter trial that included patients with GCS < 12 and who were hypotensive with SBP < 90. Patients received either a 1g bolus followed by a 1g infusion over 8 hours, or a 2 g bolus only. The authors subdivided these patients into early administration (<45 minutes after injury) or late (45 minutes to 2 hours after injury).

Here are the factoids:

  • There were 354 patients in the early administration group and 259 in the late group
  • All outcomes, including 1 month and 6 month mortality and the extended Glasgow outcome scale were not significantly different between early and late groups (exact numbers were not given)
  • There was no difference in secondary complications between the groups (again, exact numbers or complication types were not given)

The authors concluded that there was no difference in outcomes in early vs later administration of TXA in these head injured patients. They suggest that patients can be given TXA anytime within two hours without loss of benefit.

Bottom line: Essentially, this ends up as a noninferiority study. The biggest question with this type of study is, do you have enough subjects to detect a significant difference? Taken to an extreme, let’s say you have 5 patients who receive a drug who are compared to 5 who did not for some mystery condition. Three who did not get the drug die (60% mortality), but only two who get it do (40% mortality). In relative terms, there was 33% decrease in mortality with the drug. But in absolute terms, it was one patient. Would anyone see this as a significant result with such small numbers?

But now multiply by a thousand, and 300 die without the drug and only 200 die who were given it. The relative difference is the same, but the absolute difference is beginning to look large and significant.

So the smaller study won’t meet the test of significance but the larger one will. The key question in the TXA study here is, do they have enough patients enrolled to show there is no real difference between the groups? I love doing back of the napkin power analyses, and I admit I certainly don’t have all the numbers and probabilities needed for a precise calculation. But the groups sizes in this study (354 vs 259) seem a bit small to achieve significance unless there are large disparities in outcomes. 

I certainly recognize that it’s just not possible to put all the relevant information for a research project into a four paragraph abstract. One would need to be able to submit 12 slide PowerPoint decks. So I’m sure more info will be available as I take in the presentation next Friday.

Here are my questions for the authors and presenter:

  • The study is nicely designed as a randomized, double-blind trial, but how did you blind one vs two doses? Did everyone get an infusion of something, TXA vs saline?
  • Why did you select 45 minutes as the cutoff for early vs late administration? Was this arbitrary or is it based some data?
  • Show us the power analysis that demonstrates the total number of patients in the study is sufficient to show us true non-significance in your results.
  • And I’m sure you will show the actual survival and complications numbers (and type) in the presentation, since they were not available in the abstract.

Reference: THE EFFECTS OF TIMING OF PREHOSPITAL TRANEXAMIC ACID ON OUTCOMES AFTER TRAUMATIC BRAIN INJURY. EAST 35th ASA, oral abstract #40.

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Resuscitation

Best Of EAST #3: More Blood Product Stuff! Cryo vs Fibrinogen Concentrate

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I’ve got more blood transfusion stuff for you today! This one isn’t exactly MTP, but it does deal with patients suffering from blood loss. Major trauma patients requiring transfusion are losing all of their clotting factors in addition to red cells and platelets. Some factors can be replaced by giving plasma. However, clotting factor I (fibrinogen) is not one of them. For that reason, most MTPs include administration of cryoprecipitate to replace it at key points in the algorithm.

However, fibrinogen replacement actually is available in two forms, cryoprecipitate (cryo) and fibrinogen concentrate (FC). These two forms have very different properties and costs. The authors from the University of Arizona Tucson massaged two years worth of data from the TQIP database. They included all trauma patients who received either cryo or FC, except for those with known clotting issues from bleeding disorders, liver disease, or anticoagulants they were taking. They analyzed differences in mortality, complications, transfusion requirements, and length of stay.

Here are the factoids:

  • A total of 85 patients received FC and 170 received cryo (?)
  • Blood product usage (red cells, plasma, and platelets) was less in the fibrinogen concentrate group (see table)
  • ICU and hospital lengths of stay were less in the FC group (see table)
  • There was no difference in complications between the two groups

The authors concluded that use of fibrinogen concentrate was associated with improvement in the outcomes they measured. They recommended that further studies be done to evaluate use of FC.

Bottom line: This study suggests that use of fibrinogen concentrate may be better than cryoprecipitate. But there are a lot of things to think about before jumping to conclusions. First, remember that this is an association paper. It cannot detect cause and effect. Blood component usage and LOS were indeed less in the FC group. But how many hundreds of other variables factor into those outcomes: specific injury pattern, ISS, body temperature, resuscitation balance, time to OR, and product availability are just a few. These and a host of others cannot be controlled easily in a study using TQIP data alone.

Next, look at the number of units of blood products given as listed in the table above. These are the average number of units given within 24 hours! These are relatively low numbers, and below what most would consider a “massive transfusion” threshold. Most of the time, we wouldn’t even think to measure fibrinogen in patients with such low blood replacement needs. Perhaps we should?

And finally, I have questions about the low number of subjects in the study. There are only 255 patients analyzed, and propensity score matching was used. This implies that overall numbers were low and that several covariates had to be considered. It seems like more subjects should have been available in the tens of thousands of patients submitted in two years to TQIP

Here are my questions for the authors and presenters:

  • Please review your statistical analysis with the audience. Why is the number of subjects so low? What did you control for in your propensity score matching and how did this impact your n?
  • Comment on the low numbers of blood products given. Do you think that patients who have such a relatively low transfusion requirement even needed a fibrinogen supplement?
  • Did you consider performing this analysis on patients who underwent massive transfusion? The effect might have been more pronounced in that group.
  • Since fibrinogen concentrate costs about 3x what cryo does, how would this factor into the math involved in deciding to use FC?

This study raises a lot of interesting questions. I hope the authors incorporate the answers into their presentation!

Reference: FIBRINOGEN SUPPLEMENTATION FOR TRAUMA PATIENTS: SHOULD YOU CHOOSE FIBRINOGEN CONCENTRATE OVER CRYOPRECIPITATE? EAST 25th ASA, oral abstract #3.

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Resuscitation

Best Of EAST #2: Pay Attention To Platelet Ratios In Your MTP!

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More MTP stuff! Every trauma center has a massive transfusion protocol, and current literature encourages them to try to achieve an “optimal” transfusion ratio. The literature has converged on a red cell to plasma ratio of somewhere between 1:1 and 2:1. Less has been written about platelet ratios, and trauma centers often don’t pay as much attention to this ratio when reviewing MTPs.

But is it important? The trauma group at the Massachusetts General Hospital examined the impact of platelet ratios on mortality in patients undergoing MTP. This was another TQIP data analysis, performed over a nine year period.

The authors defined massive transfusion as ten or more units of PRBC in the first 24 hours, or any number of units of red cells, plasma, or platelets given within the first four hours. They also defined “balanced” as a ratio of RBC to FFP and RBC to platelets <2. Multivariate regression analysis was performed to gauge the impact of ratios and achievement of a balanced resuscitation on 24-hour mortality.

Here are the factoids:

  • A total of 7,520 patients in the dataset underwent MTP
  • Nearly 83% achieved RBC to FFP balance, but only 6% had RBC to platelet balance (!)
  • Patients with both balanced FFP and platelets had the lowest mortality at 24 hours
  • Mortality increased by 2x with unbalanced plasma, a little more than 2x with unbalanced platelets, and 3x if both were out of balance (see figure)

The authors concluded that the platelet component of the MTP was frequently out of balance, and that it is associated with mortality to a greater degree than with unbalanced plasma.

Bottom line: This paper confirms my observations that trauma centers pay a lot more attention to the red cell to plasma ratio and don’t get as excited when the platelets are out of line. Part of this is probably due to confusion over how to count platelet packs. Typically they are delivered in packs called “pheresis” or “apheresis.” Each is the equivalent of about 6 units of platelets (check with your blood bank for more exact numbers). This means that a ratio of 6 RBC to 5 plasma to 1 platelets would be considered balanced. But a ratio of 28:28:2 would not.

According to this abstract, the use of sufficient platelets is important. This makes sense. However, the exact mechanism cannot be determined from this type of study. It could be a direct effect of not having enough platelets to form good clot. Or it could be something completely outside the clotting mechanism, just an association with something in the care processes that occurs as these patients undergo resuscitation. 

The why doesn’t matter so much, though. This abstract presents compelling data that suggests that we really need to pay attention to the platelet ratios given during the MTP. They should be analyzed just as closely as plasma ratios during PI review, and changes to the MTP process implemented to normalize this important ratio.

Here are my questions for the authors and presenter:

  • There is a statement in the methods section that is not clear. “only patients with steady RBC/PLT and RBC/FFP ratios between 4-and 24-hr were analyzed.” What is your definition of “steady?”
  • Did you see any mortality patterns in the data you analyzed that might suggest why lower platelet volumes were more deadly?

This was a nicely done abstract, and I look forward to the live presentation and the finished manuscript!

Reference: DON’T FORGET THE PLATELETS: BALANCED TRANSFUSION AND THE INDEPENDENT IMPACT OF RBC/PLT RATIO ON MORTALITY IN MASSIVELY TRANSFUSED TRAUMA PATIENTS. EAST 25th ASA, Oral abstract #1.

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