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Pharmacy

Unfractionated vs Low Molecular Weight Heparin For Trauma Patients

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In my last post, I described some of the telltale signs that could be seen in a trauma center’s TQIP report that might suggest there are issues with how they go about providing prophylaxis for venous thromboembolism for their patients. Today, I will analyze a systematic review and meta-analysis of a collection of research that compared the efficacy and safety of unfractionated heparin (UFH) to low molecular weight heparin (LMWH) specifically for trauma patients.

First, it’s important to understand the concept of research quality. There is a huge amount of research published these days, and it varies considerably in how well it is designed, executed, and analyzed. Here is a diagram that illustrates the levels of quality and the volume of research published at each level. By quality, I mean the applicability to clinical treatment of actual humans. For this reason, test tube and animal research are low on the pyramid.

The research that most people consider to be the “gold standard” (randomized, controlled, double blind) is very close to the top. There is one class that, if conducted properly, may even be better. That is the systematic review and meta-analysis.

Most people have heard of meta-analysis, and it can be very good by itself. This combines lots of smaller studies into one larger one. However, it may hampered by the quality of the studies included in the meta-analysis. The tenet of “garbage in equals garbage out” certainly holds. But a systematic review takes that one step further.

The systematic review compiles all possible studies related to a small set of research questions, and usually concentrates on the ones with the highest quality research design. The quality of each of the studies is evaluated, and a meta-analysis is then performed on the best. Results are usually represented in a forest plot. This is an easy way to illustrate the estimated results from a number of studies that address the same question. There is also an entry that shows the relative strength of all of the studies combined. Here’s an example:

There are seven studies included, and each is displayed with its risk ratio (RR) and confidence interval (CI). The final diamond is the combined RR and CI for the entire group of studies. In the example above, note that most of the studies have CI bars that extend over the risk ratio = 1 line, meaning they may not be significant. But when taken together, the final risk ratio of the group is well under 1.0 and does not cross over it, denoting significance.

Let’s now apply this concept to a group of studies comparing UFH and LMWH for prevention of VTE for trauma patients. Based on keyword search, the authors identified 1,227 records for screening. Of those, only 40 were tentativley found to directly address the question. After in-depth analysis, only 12 were eligible for final review. For various reasons, only about 1 in 100 papers could be used to try to analyze the question. This always shocks me.

Here are the efficacy results. All are statistically significant, and all but mortality were stated with moderate certainty. The mortality number had low certainty due to the fact there were only three studies and confidence intervals were very wide.

  • Deep venous thrombosis: LMWH reduced by about 35% compared to UH
  • Pulmonary embolism: LMWH reduced by 44% although certainty was low
  • Any VTE: LMWH reduced by about 30%
  • Mortality: LMWH reduced by 56% (low to very low certainty)

Safety was also analyzed, including bleeding events, unexpected return to OR, heparin induced thrombocytopenia (HIT), and “any adverse events.” All of the Total Confidence Interval diamonds were situated on the risk ratio = 1 line, denoting no significant change when comparing LMWH vs UH.  However, quality of this data was noted to be low due to the quality of the individual studies. This means that we do not really know the answer to the safety question with any certainty yet.

Bottom line: This is one of the best summaries of our research on UH vs LMHW to date. It broadly reviewed the available literature and found only a small subset to analyze. It is clear that LMWH is superior for prevention of DVT and VTE overall. However, the impact on pulmonary embolism and death is still unclear.

As far as safety, the studies are still of quality that is too low to use for a decent analysis. Although this study did not detect any increase in complications, we still can’t say with any degree of certainty.

So what does it all mean? We have been using LMWH for decades now. Most likely, if there were regular complications like bleeding, unexpected return to OR, or HIT we would have definitely noticed it by now. Fortunately, we only have a few anecdotes and case reports to scare us off.

Overall, there is good support for the use of LMWH exclusively in most trauma patients. However, the prescribing provider should always assess patient factors that may suggest that UH might be better is a specific case. But remember that using UH trades an unclear/unlikely safety advantage for a recognized decrease in efficacy.

Reference: Efficacy and safety of low molecular weight heparin versus unfractionated heparin for prevention of venous thromboembolism in trauma patients. Ann Surgery 275(1):19-28, 2022.

Pharmacy

VTE Prophylaxis And TBI

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There has been a tremendous amount of gnashing of teeth regarding venous thromboembolism (VTE) prophylaxis in patients with blood in their head. This means any kind of blood: subarachnoid / epidural / subdural hematomas as well as intraparenchymal hemorrhage.

Trauma professionals have traditionally been hesitant to give any type of anticoagulant to a patient who has just bled, or who may be at risk for bleeding in the very near future. This becomes even more important in areas like the brain where management is a bit more difficult and adverse events can be devastating.

For this reason, our neurosurgical colleagues frequently like to steer the ship and dictate what type of VTE prophylaxis can be given, and when. Unfortunately, much of their advice may be driven by dogma and what they learned about the subject during their training. Having studied hundreds of TQIP reports over the past few years, I’ve learned to pick out hospitals that are relying on the advice of non-trauma surgeons to direct the prophylactic regimen.

Here are two dead giveaways that something is amiss. First, look at your TQIP report table titled “Pharmacologic VTE Prophylaxis Type.”

Compare the use of unfractionated heparin vs low molecular weight heparin (LMWH). This hospital has a huge variance from the norm compared to other comparable trauma centers. This means that “someone” is dictating its use for some subset of patients.

In my experience, this is typically a neurotrauma thing. Now take a look at the TQIP table titled “Pharmacologic VTE Prophylaxis.” Specifically, look at the “Severe TBI” cohort for time to VTE prophylaxis.

It is very clear that there is a significant delay to administering VTE prophylaxis to TBI patients. These two data points indicate that there is some reluctance to giving appropriate treatment to these patients.

The literature is clear that VTE prophylaxis is important in many trauma patients, including those with serious head injury. There are three questions that need to be answered to settle on optimal care:

  1. Which chemoprophylaxis is best, unfractionated or low molecular weight heparin?
  2. Is it better to give the selected agent earlier or later?
  3. If earlier is better, how early can we give it?

I will address each of these questions in this series of posts, focusing on neurotrauma patients. In order to try to toss out dogma, the literature I cite will be recent, no more than about two years old. So join me for battle next week as we have unfractionated vs low molecular weight heparin face off.

Thanks to Jim Sargent from Beth Israel Deaconess Medical Center for suggesting this topic.

Philosophy

The Logroll: Toward The Fractures Or Away From Them?

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You know the routine. Trauma patients get the usual ATLS primary survey secondary survey double play. An important part of the secondary survey is examining the back. Without it, you’ve failed to inspect nearly 50% of the body.

Usually this part is easy, especially if you’ve got a reasonably sized trauma team. Two or three people carefully logroll the patient, one stabilizes the cervical spine, while another inspects and palpates the back. At our center, we routinely logroll to the patient’s left side, because the examiner is normally stationed at their right.

But what if they have fractured extremities? Which way to go?

Once again, this is philosophy unsupported by literature. No one does studies on mundane stuff like this. The real questions are, rolling to which side will create the least additional injury and cause the least pain?

First, let’s address the injury question. The usual rule is that all patients with fractures must have them splinted before they leave the resus room. This decreases pain, bleeding, and the opportunity for additional tissue injury. Ideally, splinting should occur before the logroll, since this maneuver can involve more movement than rolling around the hospital or moving back and forth to x-ray tables.

Next, there’s pain. Make sure that your patient has been given adequate analgesia early in the resuscitation, and sedation if indicated.

Finally, the roll. My rule is that the fractures should be rotated upwards, with helpers stabilizing each splinted extremity to keep them aligned. Avoid rolling the patient onto their own fractures (fractures down). The combination of weight and movement can and will shift the broken bones, causing exactly what you’ve sought to avoid!

Resuscitation

Blunt Traumatic Arrest In Kids: Are They Little Adults?

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Over and over, we hear that children are not just little adults. They are a different size, a different shape. Their “normal” vital signs are weird. Drug doses are different; some drugs don’t work, some work all too well.

But in many ways, they recover more quickly and more completely after injury. What about after what is probably the biggest insult of all, cardiac arrest after blunt trauma? The NAEMSP and the ACS Committee on Trauma previously released a statement regarding blunt traumatic arrest (BTA):

 “Resuscitation efforts may be withheld in any blunt trauma patient who, based on out-of-hospital personnel’s thorough primary patient assessment, is found apneic, pulseless, and without organized ECG activity upon arrival of EMS at the scene.“

The groups specifically point out that the guidelines do not apply to the pediatric population due to the scarcity of data for this age group.

The Children’s Hospital of Los Angeles and USC conducted a study of the National Trauma Data Bank, trying to see if children had a better outcome after this catastrophic event. Patients were considered as children if they were up to and including age 18.

Here are the factoids:

  • Of 116,000 pediatric patients with blunt trauma, 7,766 had no signs of life (SOL) in the field (0.25%)
  • The typical male:female distribution for trauma was found (70:30)
  • 75% of those without SOL in the field never regained them. Only 1.5% of these survived to discharge from the hospital.
  • 25% regained SOL with resuscitation, and 14% of them were discharged alive.
  • 499 patients underwent ED thoracotomy, and only 1% survived to discharge. There was no correlation of thoracotomy with survival.
  • It appeared that there was a tendency toward survival for the very young (age 0-4) without SOL, but statistical analysis did not bear this out

Bottom line: Children are just like little adults when it comes to blunt cardiac arrest after trauma. Although it is a retrospective, registry-based study, this is about as big as we are likely to see. And don’t get suckered into saying “but 1.5% with no vital signs ever were discharged!” This study was not able to look at the quality of life of survivors, but there is usually significant and severe disability present in the few adult survivors after this event.

Feel free to try to re-establish signs of life in kids with BTA. This usually means lots of fluid and/or blood. If they don’t respond, then it’s game over. And, like adults, don’t even think about an emergency thoracotomy; it’s dangerous to you and doesn’t work!

Reference: Survival of pediatric blunt trauma patients presenting with no signs of life in the field. J Trauma 77(3):422-426, 2014.

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.