Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial (PPOWER)
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| ClinicalTrials.gov Identifier: NCT03477006 |
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Recruitment Status :
Recruiting
First Posted : March 26, 2018
Last Update Posted : November 26, 2018
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Sponsor:
Jason Sperry
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh
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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 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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
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Primary Outcome Measures :
- 28 day all cause mortality [ Time Frame: 28 days from admission ]28 day all cause mortality
Secondary Outcome Measures :
- multiple organ failure [ Time Frame: 28 days from admission ]multiple organ failure using the Denver post-injury MOF score
- 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 |
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
Ground level fall
Penetrating brain injury
CPR > 5 mins with out ROSC
Isolated Burn
Isolated Drowning or Hanging
No Intravenous or Intraosseous access
Prisoner
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
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Jason L Sperry, MD,MPH 412-647-3065 sperryjl@upmd.edu | |
| Principal Investigator: Jason L Sperry, MD,MPH | |
Sponsors and Collaborators
Jason Sperry
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Jason Sperry, MD | University of Pittsburgh |
| Responsible Party: | Jason Sperry, Professor of Surgery and Critical Care Medicine, University of Pittsburgh |
| ClinicalTrials.gov 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:
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Shock, Hemorrhagic Hemorrhage Pathologic Processes Shock |