PreHospital Air Medical Plasma Trial

NCT01818427 | Completed Phase 3 Results DMC

• 1 other identifier: 11152002 IND 15117
• Study Type: interventional
• Target: 523
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of the prehospital infusion during air transport of 2 units of AB plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional care.

Conditions

Hemmorhagic Shock During Air Medical Transport

Keywords

hemmorhagic shock, plasma, air medical transport, randomized, multicenter

Outcome Measures

Primary Outcomes (1)

• Our Primary Outcome for the Proposal Will be 30 Day Mortality

  All cause 30 day mortality using imputation for those with missing 30 day mortality.

  30 days

Secondary Outcomes (4)

• Twenty Four-Hour Blood Transfusion Requirements

  at twenty four hours

• In-hospital Mortality

  during hospitalization

• Multiple Organ Failure

  during hospitalization

• Acute Lung Injury (ALI) and Transfusion Related Acute Lung Injury (TRALI)

  hospitalization

Study Arms (2)

plasma

EXPERIMENTAL

infusion of 2 units of plasma

Biological: infusion of 2 units of plasma

standard air medical care

NO INTERVENTION

control group

Interventions

infusion of 2 units of plasma BIOLOGICAL

infusion of 2 units of plasma

plasma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Jason Sperry: lead
• University of Texas: collaborator
• University of Louisville: collaborator
• Vanderbilt University: collaborator
• Case Western Reserve University: collaborator
• The University of Tennessee, Knoxville: collaborator
• JPS Health Network: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• 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

• Wu J, Moheimani H, Li S, Kar UK, Bonaroti J, Miller RS, Daley BJ, Harbrecht BG, Claridge JA, Gruen DS, Phelan HA, Guyette FX, Neal MD, Das J, Sperry JL, Billiar TR. High Dimensional Multiomics Reveals Unique Characteristics of Early Plasma Administration in Polytrauma Patients With TBI. Ann Surg. 2022 Oct 1;276(4):673-683. doi: 10.1097/SLA.0000000000005610. Epub 2022 Jul 19.

  PMID: 35861072 DERIVED

• Gruen DS, Guyette FX, Brown JB, Okonkwo DO, Puccio AM, Campwala IK, Tessmer MT, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Neal MD, Zuckerbraun BS, Yazer MH, Billiar TR, Sperry JL. Association of Prehospital Plasma With Survival in Patients With Traumatic Brain Injury: A Secondary Analysis of the PAMPer Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2016869. doi: 10.1001/jamanetworkopen.2020.16869.

  PMID: 33057642 DERIVED

• Gruen DS, Brown JB, Guyette FX, Vodovotz Y, Johansson PI, Stensballe J, Barclay DA, Yin J, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Neal MD, Zuckerbraun BS, Billiar TR, Sperry JL; PAMPer study group. Prehospital plasma is associated with distinct biomarker expression following injury. JCI Insight. 2020 Apr 23;5(8):e135350. doi: 10.1172/jci.insight.135350.

  PMID: 32229722 DERIVED

• Pusateri AE, Moore EE, Moore HB, Le TD, Guyette FX, Chapman MP, Sauaia A, Ghasabyan A, Chandler J, McVaney K, Brown JB, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Sperry JL. Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials. JAMA Surg. 2020 Feb 1;155(2):e195085. doi: 10.1001/jamasurg.2019.5085. Epub 2020 Feb 19.

  PMID: 31851290 DERIVED

• Sperry JL, Guyette FX, Brown JB, Yazer MH, Triulzi DJ, Early-Young BJ, Adams PW, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Duane TM, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Rosengart MR, Forsythe RM, Billiar TR, Yealy DM, Peitzman AB, Zenati MS; PAMPer Study Group. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326. doi: 10.1056/NEJMoa1802345.

  PMID: 30044935 DERIVED

• Reynolds PS, Michael MJ, Cochran ED, Wegelin JA, Spiess BD. Prehospital use of plasma in traumatic hemorrhage (The PUPTH Trial): study protocol for a randomised controlled trial. Trials. 2015 Jul 30;16:321. doi: 10.1186/s13063-015-0844-5.

  PMID: 26220293 DERIVED

Results Point of Contact

• Title: Dr. Jason Sperry
• Organization: University of Pittsburgh

sperryjl@upmc.edu

412 6922850

Study Officials

• Jason L Sperry, MD,MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 26, 2013
• Study Start: May 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 8, 2021
• Results First Posted: October 9, 2018

Record last verified: 2021-04

Locations

US (1)