Pragmatic, Randomized Optimal Platelet and Plasma Ratios
United States, Canada680 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 ra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24-hour Mortality
Timeframe: First 24 hours after ED admission
2
30-day Mortality
Timeframe: First 30 days after ED admission
3
Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE)
Timeframe: From time of ED admission, for up to 72 hours
Trial details
NCT IDNCT01545232
SponsorThe University of Texas Health Science Center, Houston