The PROPPR Randomized Clinical Trial

04 Feb
February 4, 2015

The PROPPR Randomized Control TrialIn the United States, trauma is the leading cause of death among patients between the ages of 1 and 44 years of age and the third leading cause of death overall. Approximately 20 to 40% of trauma deaths occur after hospital admission and are a result of massive hemorrhage.  There have been no large, multi-center, randomized clinical trials with survival as a primary end point that support optimal trauma resuscitation practices with approved blood products and therefore there are many conflicting recommendations. The Prosective Observational Multicenter Major Trauma Transfusion (PROMMT) Trial demonstrated that many clinicians were transfusing patients with blood products in a ratio of 1:1:1 or 1:1:2 and that early transfusion of plasma was associated with improved 6-hour survival after admission.

The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial was designed to address the effectiveness and safety of 1:1:1 transfusion ratio vs 1:1:2 in patients with trauma who were predicted to receive a massive transfusion.

What is Damage Control Resuscitation (DCR)? (25631636)

Damage Control Resuscitation (DCR) is the concept of rapid hemorrhage control through:

  1. Permissive Hypotension
  2. Hemostatic Resuscitation (Massive Transfusion Protocol)
  3. Hemorrhage Control (Damage Control Surgery)

Early administration of blood products in a balanced ratio (1:1:1 for units of plasma to platelets to red blood cells helps treat intravascular volume deficits, acute coagulopathy of trauma, preserve oxygen-carrying capacity, and prevention of dilutional coagulopathy.

Damage Control Resuscitation

What is the definition of a massive transfusion? (15064258)

Historically, massive transfusion is defined as the replacement of > 10 Units of PRBCs within 24 hours or arbitrarily defined as:

  1. The replacement of a patient’s total blood volume in less than 24 hours
  2. The acute administration of more than half the patient’s estimated blood volume over 3 hours

Massive Blood Transfusion

What is the Basic Breakdown of The PROPPR Randomized Clinical Trial? JAMA Feb 2015

Hot Off the Press

What they Did:

  • Determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio vs 1:1:2 ratio
  • Phase 3, multisite, randomized clinical trial of 680 severely injured patients
  • 12, level 1 trauma centers in North America

Primary Outcome:

  • 24-hour and 30-day all-cause mortality

Secondary Outcomes:

  • Time to hemostasis
  • Blood product volumes transfused
  • Complications
  • Incidence of surgical procedures
  • Functional status

Results:

  • No statistically significant difference in mortality at 24 hours or at 30 days
  • Exsanguination in first 24 hours (secondary outcome) significantly decreased in the 1:1:1 group vs 1:1:2 group (9.2% vs 14.6%; p = 0.03)
  • More patients achieved hemostasis in the 1:1:1 group vs 1:1:2 group (86% vs 78%; p = 0.006)
  • More plasma (Median 7 Units vs 5 Units) and platelets (Median 12 Units vs 6 Units) were used in the 1:1:1 ratio vs 1:1:2 ratio
  • No difference in complications between the two strategies

Limitations:

  • This study was appropriately powered to detect a 10% difference in mortality between the 1:1:1 and 1:1:2 groups, however the study could not definitively establish a benefit < 10%
  • Physicians not blinded once transfusion protocol begun
  • Unable to completely exclude patients with an unsurvivable brain injury (23% of deaths at 24 hrs and 38% of deaths at 30 days)

Study Conclusion: Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio vs 1:1:2 ratio did not result in significant differences in mortality at 24 hours or 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination at 24 hours.

Buzz on Twitter

Karim Brohi

Anand Swaminathan

 

Take Home Message

Ultimately, this was an underpowered study to determine < 10% mortality benefit at 24 hours and 30 days, however the 1:1:1 transfusion strategy decreases death from exsanguination at 24 hours, achieves more rapid hemostasis, and has no additional complications associated with it.

 

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Bibliography

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Salim Rezaie

Emergency Physician at Greater San Antonio Emergency Physicians (GSEP)
Creator & Founder of R.E.B.E.L. EM
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10 replies

Trackbacks & Pingbacks

  1. […] várias revisões no FOAM sobre o estudo PROPPR, aqui estão algumas delas: • REBEL EM: The PROPPR Randomized Clinical Trial • Rory Spiegel at EM Nerd: The Adventure of the Blanched Soldier • Ryan Radecki at EM […]

  2. […] the effect of 1:1:1 (adding platelets as the third blood product) to vs. 1.5:1:1 – check out Salim’s awesome review . Although there was no difference in over-all mortality at 24 hours and 30 days, death from […]

  3. […] a suggestion that this trial is under-powered to demonstrate superiority of 1:1:1. Read more from Salim at REBEL EM and listen to Ken and Salim discuss it at […]

  4. […] Salim Rezaie at REBEL EM. The PROPPR Randomized Clinical Trial […]

  5. […] More: The PROPPR Randomized Clinical Trial (REBEL […]

  6. […] Salim Rezaie at REBEL EM. The PROPPR Randomized Clinical Trial […]

  7. […] is all atwitter about it. Check out HippoEM’s discussion, REBEL EM’s (quite literally) beautiful breakdown, and EM Literature of Note’s great […]

  8. […] trauma versus 1:1:2 (plasma/platelets/RBCs). HIPPO EM has a nice review of the landmark study and a more in depth review from REBEL EM.. […]

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