Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial (PPOWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03477006
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : November 26, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh

Brief Summary:
Despite advances in trauma resuscitation, a paucity of therapeutic interventions are available early enough to reduce the downstream morbidity and mortality attributable to hemorrhage, shock and coagulopathy. Due to the time sensitive nature of the treatment of hemorrhage, the ideal resuscitation intervention would entail use of a blood product containing all essential hemostatic components, closest to time of injury, where prevention or reversal of the devastating downstream consequences of shock and coagulopathy can occur. This proposal will characterized the efficacy of whole blood resuscitation initiated in the prehospital setting to patients in hemorrhagic shock which represents this ideal intervention post-injury. These results will have great potential to dramatically change the way trauma resuscitation occurs today.

Condition or disease Intervention/treatment Phase
Hemorrhagic Shock Biological: Whole blood Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic Prehospital Group O Whole Blood Early Resuscitation (PPOWER) Trial: A Prospective, Interventional,Randomized, 3 Year, Pilot Clinical Trial
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: LTLR-WB
Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care
Biological: Whole blood
Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood

No Intervention: Standard Care
Redeiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care

Primary Outcome Measures :
  1. 28 day all cause mortality [ Time Frame: 28 days from admission ]
    28 day all cause mortality

Secondary Outcome Measures :
  1. multiple organ failure [ Time Frame: 28 days from admission ]
    multiple organ failure using the Denver post-injury MOF score

  2. 24 hour mortality [ Time Frame: 24 hours from admission ]
    24 hour mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Injured patients being transport via an air medical service with hypotension (SBP < 90mmHg with tachycardia >108 OR SBP<70 without the tachycardia requirement)

Exclusion Criteria:

Age < 18 or > 89 years

Ground level fall

Penetrating brain injury

CPR > 5 mins with out ROSC

Isolated Burn

Isolated Drowning or Hanging

No Intravenous or Intraosseous access


Referral Hospital Admission

Wearing No PPOWER bracelet

Objection to study voiced by subject or family at scene

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03477006

United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jason L Sperry, MD,MPH    412-647-3065   
Principal Investigator: Jason L Sperry, MD,MPH         
Sponsors and Collaborators
Jason Sperry
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jason Sperry, MD University of Pittsburgh

Responsible Party: Jason Sperry, Professor of Surgery and Critical Care Medicine, University of Pittsburgh Identifier: NCT03477006     History of Changes
Other Study ID Numbers: R34HL135224 ( U.S. NIH Grant/Contract )
R34HL135224 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Shock, Hemorrhagic
Pathologic Processes