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

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ClinicalTrials.gov Identifier: NCT03477006

Recruitment Status : Not yet recruiting

First Posted : March 26, 2018

Last Update Posted : August 16, 2018

See Contacts and Locations

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Jason Sperry, University of Pittsburgh

Study Description

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 Design


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
Estimated Study Start Date :	October 1, 2018
Estimated Primary Completion Date :	December 30, 2020
Estimated Study Completion Date :	January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

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

Contacts and Locations

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
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Jason Sperry

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Jason Sperry, MD	University of Pittsburgh

More Information


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:	August 16, 2018
Last Verified:	August 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 Hemorrhage Pathologic Processes Shock

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