Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR)
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Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Trauma |
Biological: 1:1:1 Blood Transfusion Ratio Biological: 1:1:2 Blood Transfusion Ratio |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pragmatic, Randomized Optimal Platelets and Plasma Ratios |
- 24-hour mortality [ Time Frame: First 24 hours after ED admission ] [ Designated as safety issue: Yes ]
- 30-day mortality [ Time Frame: First 30 days after ED admission ] [ Designated as safety issue: Yes ]
- Coagulation and inflammatory phenotypes at emergency department admission and over time. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Hospital fee, ventilator free and ICU free days [ Time Frame: first 30 days after ED admission ] [ Designated as safety issue: No ]
- Time to hemostasis, major surgical procedures, incidence of transfusion related serious adverse events. [ Time Frame: ED admission to hospital discharge or 30 days, whichever comes first ] [ Designated as safety issue: Yes ]
- Amount of blood products given to hemostasis, amount of blood products given from hemostasis to 24 hours after ED admission [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- Functional status at time of hospital discharge, initial hospital discharge status [ Time Frame: Hospital discharge or 30 days, whichever comes first ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 580 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1:1:1 Blood Transfusion Ratio |
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.
|
| Active Comparator: 1:1:2 Blood Transfusion Ratio |
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.
|
Detailed Description:
Background: Multiple observational studies have reported that blood product component ratios (i.e., plasma:platelets:RBCs) that approach the 1:1:1 ratio, found in fresh whole blood, are associated with significant decreases in truncal hemorrhagic death and in overall 24-hour and 30-day mortality among injured patients. The rationale for the 1:1:1 ratio is that the closer a transfusion regimen approximates whole blood, the faster hemostasis will be achieved with minimum risk of coagulopathy. The current DoD guideline specifies the use of 1:1:1, and this practice is followed on almost all combat casualties. In other observational studies, leading centers have reported good outcomes across a range of different blood product ratios. For example, a 1:2 plasma:RBC ratio is used with little guidance regarding platelets. The proposed randomized trial is intended to resolve debate and uncertainty regarding optimum blood product ratios.
Study Design: Randomized, two-group, controlled Phase III trial with a Vanguard stage. Equal random allocation to treatment using stratified, permuted blocks with randomly chosen block sizes and stratification by site.
Objective: To conduct a Phase III multi-site, randomized trial in subjects predicted to have a massive transfusion, comparing the efficacy and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells (the closest approximation to reconstituted whole blood) with the 1:1:2 ratio. The co-primary outcomes will be 24-hour and 30-day mortality. The PROPPR Trial will be conducted with exception from informed consent (EFIC). Additionally, laboratory data from the trial will add to the understanding of trauma induced coagulopathy (TIC) and inflammation.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 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.
Contacts and Locations| Contact: Jeanette Podbielski, RN | 713-500-6407 | Jeanette.M.Podbielski@uth.tmc.edu |
| United States, Alabama | |
| University of Alabama | Not yet recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Carolyn Williams 205-996-4982 cswilliams@uabmc.edu | |
| Principal Investigator: Jeffrey Kerby, MD | |
| United States, Arizona | |
| University of Arizona | Not yet recruiting |
| Tucson, Arizona, United States, 85721 | |
| Contact: Coy Collins 520-626-2876 ccollins@surgery.arizona.edu | |
| Principal Investigator: Terence O'Keeffe, MD | |
| United States, California | |
| University of Southern California, Los Angeles | Not yet recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Jay Zhu 323-226-7180 jzhu@usc.edu | |
| Principal Investigator: Kenji Inaba, MD | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Mary Nelson 415-206-4012 nelsonm@sfghsurg.ucsf.edu | |
| Principal Investigator: Mitchell Cohen, MD | |
| United States, Maryland | |
| University of Maryland School of Medicine | Not yet recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Lisa Gettings 410-328-0288 lgettings@stapa.umm.edu | |
| Principal Investigator: Thomas Scalea, MS | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45221 | |
| Contact: Dina Gomaa 513-558-6305 dina.gomaa@uc.edu | |
| Principal Investigator: Peter Muscat, MD | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Samantha Underwood 503-494-8481 underwos@ohsu.edu | |
| Principal Investigator: Martin Schreiber, MD | |
| United States, Tennessee | |
| University of Tennessee Health Science Center | Recruiting |
| Memphis, Tennessee, United States, 38103 | |
| Contact: Suzanne Wilson 901-448-1133 swilso34@uthsc.edu | |
| Principal Investigator: Timothy Fabian, MD | |
| United States, Texas | |
| University of Texas Health Science Center- Memorial Hermann Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Tim Welch, NREMT-P, FP-C 713-500-7298 Timothy.Welch@uth.tmc.edu | |
| Principal Investigator: Bryan Cotton, MD | |
| United States, Washington | |
| University of Washington- Harborview Medical Center | Not yet recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Pat Klotz 206-744-7724 pklotz@u.washington.edu | |
| Principal Investigator: Eileen M. Bulger, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Pam Walsh 414-805-6876 pwalsh@mcw.edu | |
| Principal Investigator: Karen Brasel, MD | |
| Canada, Ontario | |
| Sunnybrook Health Science Center | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Sandy Trpcic 416-480-6100 ext 7322 Sandy.Trpcic@sunnybrook.ca | |
| Principal Investigator: Sandro Rizoli, MD, PhD | |
| Study Director: | John Holcomb, MD | The University of Texas Health Science Center, Houston |
More Information
Additional Information:
No publications provided
| Responsible Party: | John Holcomb, Study Director, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT01545232 History of Changes |
| Other Study ID Numbers: | HSC-GEN-11-0174, U01HL077863 |
| Study First Received: | February 29, 2012 |
| Last Updated: | October 4, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Massive Transfusion Red Blood Cells Transfusion-related acute lung injury (TRALI) Trauma Coagulopathy Trauma Induced Coagulopathy Plasma Platelets Mortality |
Wounds and Injuries Shock, Hemorrhagic Shock Pathologic Processes Hemorrhage Hemostatics Coagulation Inflammation |
ClinicalTrials.gov processed this record on May 23, 2013