Resuscitation Outcomes Consortium (ROC) Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR)
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August 2012-December 2013
Dataset(s) Last Updated
January 3, 2018
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To determine if there is a reduction in massive transfusion complication and mortality rates by comparing subjects who received plasma, platelets, and red blood cells in a 1:1:2 ratio with those who received a more traditional transfusion ratio of 1:1:1.
Individuals who experience massive blood loss due to trauma, surgery, or other means of hemorrhage are in need of rapid blood replacement. Components of blood transfusions typically approximate the composition of whole blood which is plasma, platelets, and red blood cells (RBC) in a 1:1:1 ratio. This ratio is often used by trauma centers but is not without complications and high mortality rates. Observational studies have reported good outcomes with other transfusion product ratios but there have been no recommendations to alter current blood replacement practices.
680 subjects that experienced severe hemorrhage and met local criteria for the highest level of trauma were included in the PROPPR study. Level of trauma was defined by site-specific criteria based on heart rate, blood pressure, respiratory rate, and mechanism of injury. Eligible subjects had to be at least 15 years or older, have experienced a recent trauma, have received a transfusion of at least one unit during transport to the hospital or within an hour of arrival at the hospital, and required a massive transfusion defined as at least 10 units of RBCs within the first 24 hours of the traumatic event.
Individuals could not be part of the trial if they were moribund, required an emergency thoracotomy, were pregnant, had burns covering more than 20% of total body surface area, or had suspected inhalation injury.
PROPPR was a pragmatic, Phase III, multicenter, prospective trial where eligible subjects were randomly assigned to one of two possible blood product replacement groups. Participating centers were located in the United States and Canadian and of the 680 total subjects, 338 received plasma, platelets, and RBC in a 1:1:1 ratio and 342 were assigned to 1:1:2 ratio group. Because participants were in a life threatening situation, the study utilized exception from informed consent.
The intervention consisted of containers of blood products prepared by each site’s blood bank and delivered to the bedside within 10 minutes. Containers for the 1:1:1 group included 6 U of plasma, 1 dose of platelets (a pool of 6 U on average), and 6 U of RBCs. Platelets were transfused first, followed by alternating RBC and plasma units. There were two containers for the 1:1:2 group that were transfused either simultaneously or sequentially. The first container included 3 U of plasma, 0 doses of platelets, and 6 U of RBC, which were transfused by alternating 2 U of RBCs and 1 U of plasma. The second container included 3 U of plasma, 1 dose of platelets (a pool of 6 U on average), and 6 U of RBCs. Platelets were transfused first, followed by alternating 2 U of RBCs and 1 unit of plasma. Transfusion of all study blood products was stopped when clinically indicated.
The primary outcome objectives were to compare 24-hour and 30-day mortality rates initiated at time of admission to the emergency department. A secondary outcome was to determine if there was a difference between times of hemostasis.
No significant differences were detected in safety or mortality rates at 24-hour or 30-day periods between those who received the 1:1:1 blood transfusion ratio and those who received 1:1:2 ratio. The 1:1:1 group demonstrated a decreased rate of exsanguination within 24 hours and had better hemostasis outcomes than those in the 1:1:2 group but there was an insignificant difference for non-fatal complications due to massive transfusion.
Holcomb JB, Tilley BC, Baraniuk S, et al. Transfusion of Plasma, Platelets, and Red Blood Cells in a 1:1:1 vs a 1:1:2 Ratio and Mortality in Patients With Severe Trauma: The PROPPR Randomized Clinical Trial. JAMA. 2015;313(5):471-482. doi:10.1001/jama.2015.12.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 719.3 KB)
- Case Report Forms (PDF - 1.6 MB)
- Manual of Operations (PDF - 43.8 MB)
- Protocol (PDF - 1.2 MB)
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