Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial
- PMID: 35881397
- PMCID: PMC9327575
- DOI: 10.1001/jamanetworkopen.2022.23619
Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial
Abstract
Importance: Blood transfusion is a mainstay of therapy for trauma-induced coagulopathy, but the optimal modalities for plasma transfusion in the prehospital setting remain to be defined.
Objective: To determine whether lyophilized plasma transfusion can reduce the incidence of trauma-induced coagulopathy compared with standard care consisting of normal saline infusion.
Design, setting, and participants: This randomized clinical trial was performed at multiple centers in France involving prehospital medical teams. Participants included 150 adults with trauma who were at risk for hemorrhagic shock and associated coagulopathy between April 1, 2016, and September 30, 2019, with a 28-day follow-up. Data were analyzed from November 1, 2019, to July 1, 2020.
Intervention: Patients were randomized in a 1:1 ratio to receive either plasma or standard care with normal saline infusion (control).
Main outcomes and measures: The primary outcome was the international normalized ratio (INR) on arrival at the hospital. Secondary outcomes included the need for massive transfusion and 30-day survival. As a safety outcome, prespecified adverse events included thrombosis, transfusion-related acute lung injury, and transfusion-associated circulatory overload.
Results: Among 150 randomized patients, 134 were included in the analysis (median age, 34 [IQR, 26-49] years; 110 men [82.1%]), with 68 in the plasma group and 66 in the control group. Median INR values were 1.21 (IQR, 1.12-1.49) in the plasma group and 1.20 (IQR, 1.10-1.39) in the control group (median difference, -0.01 [IQR, -0.09 to 0.08]; P = .88). The groups did not differ significantly in the need for massive transfusion (7 [10.3%] vs 4 [6.1%]; relative risk, 1.78 [95% CI, 0.42-8.68]; P = .37) or 30-day survival (hazard ratio for death, 1.07 [95% CI, 0.44-2.61]; P = .89). In the full intention-to-treat population (n = 150), the groups did not differ in the rates of any of the prespecified adverse events.
Conclusions and relevance: In this randomized clinical trial including severely injured patients at risk for hemorrhagic shock and associated coagulopathy, prehospital transfusion of lyophilized plasma was not associated with significant differences in INR values vs standard care with normal saline infusion. Nevertheless, these findings show that lyophilized plasma transfusion is a feasible and safe procedure for this patient population.
Trial registration: ClinicalTrials.gov Identifier: NCT02736812.
Conflict of interest statement
Figures


Similar articles
-
The efficacy and safety of pre-hospital plasma in patients at risk for hemorrhagic shock: an updated systematic review and meta-analysis of randomized controlled trials.Eur J Trauma Emerg Surg. 2024 Dec;50(6):2697-2707. doi: 10.1007/s00068-024-02461-7. Epub 2024 Feb 17. Eur J Trauma Emerg Surg. 2024. PMID: 38367091 Free PMC article.
-
French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial.Trials. 2020 Jan 22;21(1):106. doi: 10.1186/s13063-020-4049-1. Trials. 2020. PMID: 31969168 Free PMC article.
-
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. JAMA Surg. 2020. PMID: 31851290 Free PMC article. Clinical Trial.
-
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. JAMA Netw Open. 2020. PMID: 33057642 Free PMC article. Clinical Trial.
-
Prehospital Freeze-Dried Plasma in Trauma: A Critical Review.Transfus Med Rev. 2024 Jan;38(1):150807. doi: 10.1016/j.tmrv.2023.150807. Epub 2023 Nov 30. Transfus Med Rev. 2024. PMID: 38114340 Review.
Cited by
-
Whole blood vs saline for MAP restoration in anesthetized piglets after non-traumatic hemorrhagic shock: an experimental study.Sci Rep. 2025 Jul 21;15(1):26497. doi: 10.1038/s41598-025-12273-3. Sci Rep. 2025. PMID: 40691285 Free PMC article.
-
Post-Reconstitution Hemostatic Stability Profiles of Canadian and German Freeze-Dried Plasma.Life (Basel). 2024 Jan 24;14(2):172. doi: 10.3390/life14020172. Life (Basel). 2024. PMID: 38398681 Free PMC article.
-
Development of a national out-of-hospital transfusion protocol: a modified RAND Delphi study.CMAJ Open. 2023 Jun 27;11(3):E546-E559. doi: 10.9778/cmajo.20220151. Print 2023 May-Jun. CMAJ Open. 2023. PMID: 37369521 Free PMC article.
-
Prise en charge non chirurgicale de l’hémorragie majeure.CMAJ. 2023 Aug 28;195(33):E1126-E1135. doi: 10.1503/cmaj.221731-f. CMAJ. 2023. PMID: 37640404 Free PMC article. Review. French. No abstract available.
-
The efficacy and safety of pre-hospital plasma in patients at risk for hemorrhagic shock: an updated systematic review and meta-analysis of randomized controlled trials.Eur J Trauma Emerg Surg. 2024 Dec;50(6):2697-2707. doi: 10.1007/s00068-024-02461-7. Epub 2024 Feb 17. Eur J Trauma Emerg Surg. 2024. PMID: 38367091 Free PMC article.
References
-
- Crowe EP, Goel R, Ness PM. Prothrombin and partial thromboplastin time. In: Moore HB, Neal MD, Moore EE, eds. Trauma Induced Coagulopathy. Springer International Publishing; 2021:265-270.
Publication types
MeSH terms
Substances
Associated data
LinkOut - more resources
Full Text Sources
Medical
Research Materials
Miscellaneous