Pragmatic, Randomized Optimal Platelet and Plasma Ratios

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.

Conditions

• Trauma

Interventions

BIOLOGICAL

1:1:1 Blood Transfusion Ratio

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.

BIOLOGICAL

1:1:2 Blood Transfusion Ratio

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Resuscitation Outcomes Consortium

  collaborator NETWORK

• Defence Research and Development Canada

  collaborator INDUSTRY

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• John Holcomb, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• United States
• Canada

Study Locations