All posts by The Trauma Pro

Performance Improvement

NFTI: A Nifty Tool To Replace The Cribari Grid?

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This two-part post will examine trauma activation triage tools. The type of triage I am discussing is not prehospital triage. In this case, it involves ensuring that a trauma activation occurs appropriately and that the trauma resuscitation team evaluates the right patients.

The Cribari grid was the mainstay for years, using a high ISS score as a surrogate for appropriate triage. But it has shortcomings. The most important one is that it relies solely on the Injury Severity Score (ISS) to determine whether a type of mistriage occurred.  As you know, the ISS is usually calculated after discharge, so it can only be applied after the fact.

A few years ago, the Baylor University in Dallas group developed an alternate method of determining who needed a full trauma team activation. They chose resource utilization as their surrogate to select these cases. They reviewed 2.5 years of their registry data (Level I center).  After several iterations, they settled on six “need for trauma intervention” (NFTI) criteria:

  • blood transfusion within 4 hours of arrival
  • discharge from ED to OR within 90 minutes of arrival
  • discharge from ED to interventional radiology (IR)
  • discharge from ED to ICU AND ICU length of stay at least 3 days
  • require mechanical ventilation during the first 3 days, excluding anesthesia
  • death within 60 hours of arrival

Patients who had at least one NFTI criterion were considered candidates for full trauma activation, and those who met none were not. Here are the factoids for this study:

  • There were a total of 2260 full trauma activations and 2348 partial activations during the study period (a little over 900 per year for each level)
  • Roughly 2/3 of full activations were NFTI +, and 1/3 were NFTI –
  • For partial activations, 1/4 were NFTI + and 3/4 were NFTI –
  • Only 13 of 561 deaths were NFTI – and all had DNR orders in place

The authors concluded that NFTI assesses anatomy and physiology using only measures of early resource utilization. They believed that it self-adjusts for age, frailty, and comorbidities, and that it is a simple and effective tool for identifying major trauma patients.

Bottom line: NFTI has become a valuable adjunct to the Cribari grid. Both decrease the number of charts that must be manually reviewed to identify true undertriage. Cribari does this by using ISS as a surrogate for the need for the trauma team; NFTI does it using key resource utilization. Combining the two can further reduce chart reviews, saving a significant amount of PI analysis time.

In my next post, I’ll review a problematic subset of inappropriately triaged patients whom I refer to as “ultimate overtriage.” These are patients for whom the trauma team may not have been needed. And I’ll show you how these may be labeled as “anti-NFTI” patients.

Reference: Asking a Better Question: Development and Evaluation of the Need For Trauma Intervention (NFTI) Metric as a Novel Indicator of Major Trauma. J Trauma Nursing 24(3):150-157, 2017.

Pharmacy

Andexanet Alfa – The Final Nail In The Coffin

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The number of patients requiring chronic anticoagulation has been increasing over the past five years. It was estimated that 7-8 million people were taking these drugs in 2020. Since then, the number of patients taking direct oral anticoagulants (DOACs) has skyrocketed, tripling. At the same time, the use of warfarin has dropped by nearly half.

There was significant concern in the early years of DOACs that they were irreversible agents. If an anticoagulated patient developed a bleed in a critical area (the brain, for example), it could become a fatal problem. Fortunately, the literature has borne out the fact that they appear to be safer than good old warfarin.

A reversal agent for rivaroxaban and apixaban was developed and approved in 2018 based on preliminary studies. A series of studies, named ANNEXA, was performed. The first two were ANNEXA-A and ANNEXA-R. These were Phase 3 trials conducted in healthy volunteers who were pre-treated with apixaban (ANNEXA-A) or rivaroxaban (ANNEXA-R). They showed reversal of “anticoagulation biomarkers” but did not assess clinical hemostasis.

Then came ANNEXA-4, which assessed patients with GI or intracranial bleeding. It monitored the same biomarker (anti-FXa) as before and noted decreased activity, with about 80% of patients achieving “excellent” or “good” hemostasis within 12 hours. However, 30-day mortality was high (15% for intracranial hemorrhage), and the incidence of thrombotic events such as stroke, DVT, PE, or MI was 10% over 30 days.

Finally, ANNEXA-I was a randomized study that examined spontaneous intracranial hemorrhage treated with andexanet alfa or the usual care (usually prothrombin complex concentrate). It found similar reductions in antiFX-a activity, and higher “effective hemostasis.” This is a fudgy number that allowed a comparison between the drug and usual care, yielding a 67% vs 53% efficacy in favor of andexanet alfa. This example was statistically significant but does not appear clinically significant. Offsetting this possible benefit was a higher number of thrombotic strokes and no change in 30-day functional outcome.

Andexanet alfa was approved based on its demonstrated effect on anti-FXa activity, not on efficacy. The company withdrew this drug just a few months ago because the series of ANNEXA studies showed minimal benefit and significant risk.

Bottom line: So what went wrong? We all focused on the mechanism. The drug clearly reduced anti-FXa activity, so it must be working, right? All too often, though, we find that treating the numbers doesn’t always solve the problem and may create more serious ones. Think tight glucose control in the ICU.

When we finally had enough data to see the high complication rates and lack of survival or functional outcome benefit, we could see it was time to pull the plug on this drug. The other major downside was its cost: about $20,000 per dose, and a second dose was nearly always required. 

So it’s time to say goodbye to Andexanet alfa. Always remember: in clinical care, outcomes are more important than whether some arbitrary lab number is “fixed.”

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Performance Improvement

The Value Of Audit Filters In Trauma Performance Improvement

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I recently read a paper in Trauma Surgery and Acute Care Open questioning the relationship between trauma audit filters and opportunities for improvement (OFI). Having concentrated on performance improvement for decades, I was taken aback by their conclusion that no individual or combination of filters performed well in predicting OFIs in their trauma patients.

Since their conclusion is in stark disagreement with my impressions of the value of audit filters, I, of course, had to read the paper in its entirety to see where my thinking had gone wrong. Or theirs.

Researchers in the Emergency & Internal Medicine and Public Health departments at Karolinska University Hospital conducted a retrospective review of 10 years of registry data on audit filter usage and subsequent opportunities for improvement identified at their morbidity and mortality conferences. These are the equivalent of the multidisciplinary trauma PI committees found at US trauma centers.

They found that the filters they studied had poor sensitivity and positive predictive value. The filters were:

  • SBP<90
  • Death within 30 days
  • ISS>15 and no trauma activation
  • Massive transfusion
  • GCS<9 without intubation
  • ISS>15 and not admitted to ICU
  • >60 minutes to first major intervention
  • >30 minutes to first CT
  • Liver or spleen injury
  • No anticoagulants within 72 hours after TBI

Without deeper reading, the authors imply that using static filters like these is of little value and that new tools should be developed.

Of course, I have to disagree. There are several issues here.

  • The trauma morbidity & mortality conference (or multidisciplinary trauma PI committee in the US) should not be the only level of PI analysis. It was not clear if there were corresponding primary review or secondary review processes at this hospital. If every case with a filter violation is sent to the committee, there will undoubtedly be many that are uninteresting and would have been filtered out at our lower levels of review.
  • I worry that this M&M conference is focusing only on the patient in question. The goal of any PI review is to help protect the next similar patient. They may not tolerate the relatively minor care issues that the current patient did.
  • It’s important not to focus only on patient harm. Many audit filters flag items associated with potential process problems. There is no guarantee of finding an OFI. The “greater than 60 minutes to first intervention” filter is a good example. Most of the time, deeper analysis will identify legitimate reasons for the delay. But the entire process must be dissected to ensure there weren’t any opportunities for improvement that need to be addressed. Most patients will suffer actual harm from the issue. But some could.
  • Trauma PI focuses more on high acuity, low occurrence events. Pulmonary embolism is rare but potentially deadly, so we devote a lot of time trying to streamline our systems for providing adequate and timely VTE prophylaxis. Thus, there will be a lot of PI “overtriage,” leading to low sensitivity and positive predictive value. It’s the price we pay to try to eliminate these “never” events.

Bottom line: In my opinion, audit filters offer a checklist of shortcuts that may identify potential opportunities for improvement. A filter violation does not guarantee that we will find anything. It doesn’t matter if the patient did well or did poorly. We certainly learn important lessons when the eventual outcome is suboptimal. But we can learn just as much by finding irregularities in care that caused no harm in this patient. It might for the next one.

A key filter that I use is something I call the grandmother test. Would I be happy if my grandmother (or my child or spouse) received this care? If not, it needs to be scrutinized even if this patient went home happy and well.

Reference: Performance of individual audit filters in predicting opportunities for improvement in adult trauma patients. Trauma Surgery & Acute Care Open. 2025;10:e001808. https://doi.org/10.1136/tsaco-2025-001808

Device

REBOA: Is This Shiny Toy Losing It’s Luster?

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REBOA has been around in one form or another for decades. It was first used by vascular surgeons to gain control of pesky bleeding. It began its move into the trauma arena in 2011 with experimental use for major hemorrhage control in swine. After successful trials, it made the jump to humans in 2015.

Its use exploded over the following decade, peaking at 127 publications in 2021.

Trauma centers across the US were clamoring to be the first in their neighborhoods to get it. However, there were a few problems:

  • It was not clear which patients would benefit from its usage.
  • The number of patients who had significant bleeding below the diaphragm or from pelvic fractures was generally low in all but the busiest centers.
  • There were significant vascular complications with disturbing frequency.

So what have we learned after about 2,000 published papers? The Eastern Association for the Surgery of Trauma (EAST) recently published another practice guideline to help us make good decisions. They conducted a systematic review and meta-analysis of 31 studies to answer six questions about REBOA use.

Here are the questions and their answers:

  1. In hemodynamically unstable trauma patients with suspected sub-diaphragmatic bleeding, should REBOA vs. no REBOA be performed before definitive hemostatic procedures to reduce time to definitive intervention, blood transfusion requirements, and mortality?  (12 studies) Unfortunately, the evidence was of low quality due to selection bias, heterogeneity across studies, and wide confidence intervals resulting from small sample sizes. The review committee gave a conditional recommendation against using REBOA for these patients. The only randomized clinical trial available actually showed increased mortality in the REBOA group. The quality of the other studies was not enough to offset this.
  2. In hemodynamically unstable trauma patients with suspected pelvic fractures, should REBOA versus no REBOA be performed, before definitive hemostatic procedures, to decrease time to definitive intervention, blood transfusion requirements, and mortality? (11 studies) Once again, the quality of the papers reviewed was low. Similar to the question above, the committee gave a conditional recommendation against using REBOA in these patients.
  3. In trauma patients with cardiac arrest OR impending cardiac
    arrest due to suspected subdiaphragmatic bleeding, should REBOA versus resuscitative thoracotomy be utilized to increase the rate of return of spontaneous circulation (ROSC), decrease time to aortic occlusion, and decrease mortality?     (13 studies) Although patients receiving REBOA had 4x lower mortality, the quality and confounding factors were so significant that the committee could not make a recommendation for or against REBOA use in this population.
  4. In trauma patients with cardiac arrest due to suspected subdiaphragmatic bleeding, should REBOA versus resuscitative thoracotomy be utilized to increase the rate of ROSC, decrease time to the aortic occlusion, and decrease mortality? (7 papers) This is a bit of slicing and dicing of the question. It applies only to patients in cardiac arrest and excludes those in whom it is “impending.” This reduced confounding data and demonstrated an identifiable decrease in mortality by more than half. Despite poor-quality data, the committee conditionally recommended the use of REBOA in this population.
  5. In hemodynamically unstable patients with subdiaphragmatic
    bleeding of non-traumatic etiology, should REBOA versus no
    REBOA be used prior to definitive hemostatic procedures, to decrease blood transfusion requirements and mortality?     (1 paper) Given that there was only one paper and the quality of the data for analysis was low, the committee could not recommend for or against REBOA use in this group.
  6. In hemodynamically stable patients with anticipated subdiaphragmatic bleeding due to placenta accreta syndrome (PAS), should REBOA vs no REBOA be performed prophylactically, prior to definitive hemostatic procedures, to decrease blood transfusion requirements and blood loss? (12 studies) The number of studies and their quality were very low, but REBOA use decreased packed red cell transfusion requirements by 3 units. The committee conditionally recommended for the use of REBOA for bleeding from placenta accreta. However, they cautioned about the possibility of complications from the procedure.

Bottom line: These recommendations are moving away from recommending REBOA for all cases with severe subdiaphragmatic or pelvic bleeding. In fact, they recommend its use only for patients actually in arrest or with placenta accreta. This last situation is very uncommon (approximately 1 in 400-500 pregnancies) but is increasing slowly over time. About half of these cases result in significant hemorrhage. 

It’s time for most centers to start revising their REBOA protocols (if you have them). For high-volume centers, continue publishing your work to help us fine-tune the use of this valuable, but not invaluable, tool!

Reference: Resuscitative Endovascular Balloon Occlusion of the Aorta in surgical and trauma patients: a systematic review, meta-analysis and practice management guideline from the Eastern Association for the Surgery of Trauma. Trauma Surg Acute Care Open. 2025 Mar 28;10(1):e001730. doi: 10.1136/tsaco-2024-001730. PMID: 40166770; PMCID: PMC11956280.