Trauma Clinical Trial
Official title:
Pragmatic, Randomized Optimal Platelet and Plasma Ratios
Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial
designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted
to receive massive transfusion ([MT] (defined as receiving 10 units or more red blood cells
(RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which
clinicians make decisions about transfusion protocols for massively bleeding patients.
PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National
Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and
the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at
Level I Adult Trauma Centers in North America.
Background: Multiple observational studies have reported that blood product component ratios
(i.e., plasma:platelets:RBCs) that approach the 1:1:1 ratio, found in fresh whole blood, are
associated with significant decreases in truncal hemorrhagic death and in overall 24-hour and
30-day mortality among injured patients. The rationale for the 1:1:1 ratio is that the closer
a transfusion regimen approximates whole blood, the faster hemostasis will be achieved with
minimum risk of coagulopathy. The current DoD guideline specifies the use of 1:1:1, and this
practice is followed on almost all combat casualties. In other observational studies, leading
centers have reported good outcomes across a range of different blood product ratios. For
example, a 1:2 plasma:RBC ratio is used with little guidance regarding platelets. The
proposed randomized trial is intended to resolve debate and uncertainty regarding optimum
blood product ratios.
Study Design: Randomized, two-group, controlled Phase III trial with a Vanguard stage. Equal
random allocation to treatment using stratified, permuted blocks with randomly chosen block
sizes and stratification by site.
Objective: To conduct a Phase III multi-site, randomized trial in subjects predicted to have
a massive transfusion, comparing the efficacy and safety of 1:1:1 transfusion ratios of
plasma and platelets to red blood cells (the closest approximation to reconstituted whole
blood) with the 1:1:2 ratio. The co-primary outcomes will be 24-hour and 30-day mortality.
The PROPPR Trial will be conducted with exception from informed consent (EFIC). Additionally,
laboratory data from the trial will add to the understanding of trauma induced coagulopathy
(TIC) and inflammation.
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