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Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR)

This study has been completed.
Sponsor:
Collaborators:
Resuscitation Outcomes Consortium
Defence Research and Development Canada
Information provided by (Responsible Party):
John Holcomb, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01545232
First received: February 29, 2012
Last updated: December 19, 2013
Last verified: December 2013

February 29, 2012
December 19, 2013
August 2012
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Absolute percent (rather than relative percent) group difference in 24-hour mortality [ Time Frame: First 24 hours after ED admission ] [ Designated as safety issue: Yes ]
  • Absolute percent (rather than relative percent) group difference in 30-day mortality [ Time Frame: First 30 days after ED admission ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01545232 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Temporal changes of laboratory values associated with coagulopathy and inflammation [ Time Frame: First 24 hours after ED admission ] [ Designated as safety issue: Yes ]
  • Recruitment target versus actual by week [ Time Frame: Duration of Vanguard- 6 months ] [ Designated as safety issue: No ]
  • Protocol compliance, count and severity of protocol deviations [ Time Frame: Duration of Vanguard stage- 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Pragmatic, Randomized Optimal Platelets and Plasma Ratios
Pragmatic, Randomized Optimal Platelets and Plasma Ratios

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Trauma
  • 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.
  • Active Comparator: 1:1:1 Blood Transfusion Ratio
    Intervention: Biological: 1:1:1 Blood Transfusion Ratio
  • Active Comparator: 1:1:2 Blood Transfusion Ratio
    Intervention: Biological: 1:1:2 Blood Transfusion Ratio

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
680
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01545232
HSC-GEN-11-0174, U01HL077863
Yes
John Holcomb, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
  • Department of Defense
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Resuscitation Outcomes Consortium
  • Defence Research and Development Canada
Study Director: John Holcomb, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP