Pragmatic, Randomized Optimal Platelet and Plasma Ratios

Completed · Phase 3

Conditions studied: Trauma

In brief

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.

Key facts

Study ID

NCT01545232

Run by

The University of Texas Health Science Center, Houston

People needed

680

Starts

2012-08-01

Expected to finish

2013-12-01

Last updated by the study team

2019-02-08

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who require the highest trauma team activation at each participating center,
• Estimated age of 15 years or older or greater than/equal to weight of 50 kg if age unknown,
• Received directly from the injury scene,
• Initiated transfusion of at least one unit of blood component within the first hour of arrival or during prehospital transport, and
• Predicted to receive a MT by exceeding the threshold score of either the Assessment of Blood Consumption (ABC) score or the attending trauma physician's judgment criteria

You may not qualify if…

• Received care (as defined as receiving a life saving intervention) from an outside hospital or healthcare facility (Procedures and care given at an outside health facility cannot be documented or controlled resulting in a high variability of standards of care and clinical outcomes.)
• Moribund patient with devastating injuries and expected to die within one hour of Emergency Department (ED) admission
• Prisoners, defined as those who have been directly admitted from a correctional facility
• Patients requiring an emergency thoracotomy
• Children under the age of 15 years or under 50 kg body weight if age unknown
• Known pregnancy in the ED
• Greater than 20% total body surface area (TBSA) burns
• Suspected inhalation injury
• Received greater than five consecutive minutes of cardiopulmonary resuscitation (CPR with chest compressions) in the pre-arrival or ED setting
• Known Do Not Resuscitate (DNR) prior to randomization
• Enrolled in a concurrent, ongoing interventional, randomized clinical trial
• Patients who have activated the "opt-out" process or patients/legally authorized representatives that refuse blood products on arrival to ED.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• University of Southern California, Los Angeles — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• University of Texas Health Science Center- Memorial Hermann Hospital — Houston, Texas, United States
• University of Washington- Harborview Medical Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Sunnybrook Health Science Center — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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