drugset / Trial / NCT01818427
PreHospital Air Medical Plasma Trial
Phase 3
Completed
523 enrolled
Jason Sperry
Case Western Reserve University · collabJPS Health Network · collabThe Methodist Hospital Research Institute · collabThe University of Tennessee, Knoxville · collabUniversity of Louisville · collabUniversity of Texas · collabVanderbilt University · collab
RandomizedParallel-groupOpen-labelHealth-services research
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2017-09
- Completion
- 2017-09
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plasma | Other / unclassified | 2 unknown | — |
Indications
No indication recorded.