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

Primary Purpose

Hemorrhagic Shock

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Whole blood
Sponsored by
Jason Sperry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Shock

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LTLR-WB

Standard Care

Arm Description

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

Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care

Outcomes

Primary Outcome Measures

28 Day All Cause Mortality
28 day all cause mortality

Secondary Outcome Measures

Incidence of Multiple Organ Failure
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
24 hour mortality

Full Information

First Posted
March 19, 2018
Last Updated
September 9, 2021
Sponsor
Jason Sperry
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03477006
Brief Title
Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial
Acronym
PPOWER
Official Title
Pragmatic Prehospital Group O Whole Blood Early Resuscitation (PPOWER) Trial: A Prospective, Interventional,Randomized, 3 Year, Pilot Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment, financial considerations and global pandemic
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Sperry
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LTLR-WB
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
Intervention Type
Biological
Intervention Name(s)
Whole blood
Intervention Description
Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood
Primary Outcome Measure Information:
Title
28 Day All Cause Mortality
Description
28 day all cause mortality
Time Frame
28 days from admission
Secondary Outcome Measure Information:
Title
Incidence of Multiple Organ Failure
Description
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])
Time Frame
28 days from admission
Title
24 Hour Mortality
Description
24 hour mortality
Time Frame
24 hours from admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35081595
Citation
Guyette FX, Zenati M, Triulzi DJ, Yazer MH, Skroczky H, Early BJ, Adams PW, Brown JB, Alarcon L, Neal MD, Forsythe RM, Zuckerbraun BS, Peitzman AB, Billiar TR, Sperry JL. Prehospital low titer group O whole blood is feasible and safe: Results of a prospective randomized pilot trial. J Trauma Acute Care Surg. 2022 May 1;92(5):839-847. doi: 10.1097/TA.0000000000003551. Epub 2022 Jan 25.
Results Reference
derived

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Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial

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