CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 680 enrolled
Drug / intervention
1:1:1 Blood Transfusion Ratio +1 morebiological
Likely dose
1:1:1 Blood Transfusion Ratio 6 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01545232
NCT01545232Phase 3Completed

Pragmatic, Randomized Optimal Platelet and Plasma Ratios

The University of Texas Health Science Center, Houston·interventional·Posted Mar 6, 2012·Updated Feb 8, 2019

In Brief

A Phase 3 clinical trial evaluating 1:1:1 Blood Transfusion Ratio and 1:1:2 Blood Transfusion Ratio for Trauma. Completed, enrolled 680 participants across 12 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrauma
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago

Interventions

1:1:1 Blood Transfusion Ratiobiological

Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.

1:1:2 Blood Transfusion Ratiobiological

Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.