Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial

NCT03477006 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: R34HL135224
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Shock

Outcome Measures

Primary Outcomes (1)

• 28 Day All Cause Mortality

  28 day all cause mortality

  28 days from admission

Secondary Outcomes (2)

• Incidence of Multiple Organ Failure

  28 days from admission

• 24 Hour Mortality

  24 hours from admission

Study Arms (2)

LTLR-WB

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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

Interventions

Whole blood BIOLOGICAL

Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood

LTLR-WB

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Injured patients being transport via an air medical service with hypotension (SBP =/\< 90mmHg with tachycardia \>108 OR SBP=/\<70 without the tachycardia requirement)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jason Sperry: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Lorence JM, Donohue JK, Iyanna N, Guyette FX, Gimbel E, Brown JB, Daley BJ, Eastridge BJ, Miller RS, Nirula R, Harbrecht BG, Claridge JA, Phelan HA, Vercruysse G, O'Keeffe T, Joseph B, Neal MD, Sperry JL. Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials. Trauma Surg Acute Care Open. 2024 Jun 25;9(1):e001465. doi: 10.1136/tsaco-2024-001465. eCollection 2024.

  PMID: 38933603 DERIVED

• 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.

  PMID: 35081595 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Jason Sperry
• Organization: University of Pittsburgh

sperryjl@upmc.edu

4128028270

Study Officials

• Jason Sperry, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery and Critical Care Medicine

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: November 20, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 6, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)