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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. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
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 3

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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

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
Receiving 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. 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])

  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
Criteria

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


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 ClinicalTrials.gov identifier (NCT number): NCT03477006


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Jason Sperry
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jason Sperry, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Jason Sperry, University of Pittsburgh:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Hemorrhagic
Hemorrhage
Pathologic Processes
Shock