Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial (PPOWER)
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ClinicalTrials.gov Identifier: NCT03477006 |
Recruitment Status :
Terminated
(Slow enrollment, financial considerations and global pandemic)
First Posted : March 26, 2018
Results First Posted : October 6, 2021
Last Update Posted : October 6, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhagic Shock | Biological: Whole blood | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 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 |
Actual Primary Completion Date : | October 30, 2020 |
Actual Study Completion Date : | October 30, 2020 |
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
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Biological: Whole blood
Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood |
No Intervention: Standard Care
Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
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- 28 Day All Cause Mortality [ Time Frame: 28 days from admission ]28 day all cause mortality
- Incidence of Multiple Organ Failure [ Time Frame: 28 days from admission ]multiple organ failure using the Denver post-injury MOF score which is a summed score and when the score is 4 or greater from 4 organ system scores, MOF is designated; 4 organ systems (pulmonary [0-3], renal [0-3], hepatic [0-3], cardiovascular [0-3])
- 24 Hour Mortality [ Time Frame: 24 hours from admission ]24 hour mortality

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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
Isolated fall from standing injury mechanism
Brain matter exposed or penetrating brain injury (GSW)
CPR > 5 mins with out ROSC
Isolated burns without evidence of traumatic injury
Isolated Drowning or Hanging
No Intravenous or Intraosseous access
Known prisoner or known pregnancy
Referral Hospital Admission
Wearing No PPOWER bracelet
Objection to study voiced by subject or family at scene

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 ClinicalTrials.gov identifier (NCT number): NCT03477006
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Jason Sperry, MD | University of Pittsburgh |
Documents provided by Jason Sperry, University of Pittsburgh:
Responsible Party: | Jason Sperry, Professor of Surgery and Critical Care Medicine, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT03477006 |
Other Study ID Numbers: |
R34HL135224 ( U.S. NIH Grant/Contract ) R34HL135224 ( U.S. NIH Grant/Contract ) |
First Posted: | March 26, 2018 Key Record Dates |
Results First Posted: | October 6, 2021 |
Last Update Posted: | October 6, 2021 |
Last Verified: | September 2021 |
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 |
Shock, Hemorrhagic Hemorrhage Pathologic Processes Shock |