- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477006
Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial (PPOWER)
Pragmatic Prehospital Group O Whole Blood Early Resuscitation (PPOWER) Trial: A Prospective, Interventional,Randomized, 3 Year, Pilot Clinical Trial
Study Overview
Detailed Description
Traumatic injury represents an incredible health care burden in the United States and worldwide. Hemorrhage is estimated to be responsible for over 40% of all trauma-related deaths. Ongoing traumatic blood loss is complicated by the well-known 'lethal triad' of coagulopathy, hypothermia and acidosis which results in further unbridled hemorrhage. Uncontrolled bleeding, resultant shock and organ dysfunction remain the leading causes of early in-hospital mortality. 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.
In-hospital resuscitation of traumatic hemorrhage has changed over the past decade. The underlying principle of current resuscitation practice focuses on preventing or reversing the effects of coagulopathy with the early use of a balanced component transfusion strategy (1:1:1 - plasma: packed red blood cells: platelets). This reconstituted strategy has also been coined 'whole blood-like' resuscitation despite being inferior compositionally to whole blood. The use of whole blood was historically the gold standard for treating hemorrhagic shock during World War I and II, prior to sweeping changes in blood banking practice. Whole blood use continues today and is thought to provide the bleeding patient the identical components they are losing with maximal resuscitative and hemostatic effects.
Recent military experiences continue to show the benefits of fresh whole blood resuscitation demonstrating significant survival and hemostatic advantages. Whole blood has also been postulated to improve microcirculatory hemodynamics, reduce the 'storage lesion' effect and minimize donor exposure risks. A recent civilian study has also demonstrated benefit using modified whole blood after arrival to the hospital where appropriate blood typing and cross matching was performed prior to transfusion. 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.
Initiation of whole blood resuscitation in the prehospital setting and continued through the in-hospital phase of treatment to patients in hemorrhagic shock represents this ideal intervention post-injury. Essential to the prehospital initiation of whole blood resuscitation in the civilian population is need for it to be transfused without the need for blood typing or cross matching. Of similar importance is the need for cold storage and recycling of any unused whole blood product, allowing maximal utility of this precious resource.
Based upon the belief that early whole blood resuscitation represents the most efficacious hemostatic resuscitation product for the management of hemorrhage, the University of Pittsburgh is currently utilizing cold stored, low titer, platelet replete-leukocyte reduced, group O whole blood (LTLR-WB) for urgent release in the emergency department, without the need for blood typing or cross matching, for patients in hemorrhagic shock. The hypothesis is that the initiation of LTLR-WB resuscitation in the prehospital setting with continuation through the in-hospital acute resuscitation phase of care will significantly reduce the morbidity and mortality attributable to hemorrhagic shock post-injury as compared to standard prehospital and in-hospital resuscitation practice. Thus, a large pragmatic clinical trial is needed to definitively establish the efficacy and safety of whole blood resuscitation initiated in the prehospital setting. Only a high quality clinical trial will provide the essential evidence to justify and provide the impetus for the use of this precious blood banking resource early post-injury. Because of the challenges associated with execution of these types of large trials particularly in the prehospital setting, it is essential to establish feasibility of this approach in a pilot study and provide experience to inform a definitive large, multicenter whole blood trial. The University of Pittsburgh has a track record of prehospital interventional trials post-injury and the clinical research infrastructure to successfully execute the following this trial.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28 Day All Cause Mortality
Time Frame: 28 days from admission
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28 day all cause mortality
|
28 days from admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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])
|
28 days from admission
|
24 Hour Mortality
Time Frame: 24 hours from admission
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24 hour mortality
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24 hours from admission
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason Sperry, MD, University of Pittsburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34HL135224 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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