Safety of Bioplasma FDP and Hemopure in rhesus macaques after 30% hemorrhage.

Autor:	Pusateri AE; Naval Medical Research Unit San Antonio, Fort Sam Houston, Texas, USA., Morgan CG; Expeditionary and Trauma Medicine, Naval Medical Research Unit San Antonio, Fort Sam Houston, Texas, USA., Neidert LE; Expeditionary and Trauma Medicine, Naval Medical Research Unit San Antonio, Fort Sam Houston, Texas, USA., Tiller MM; Expeditionary and Trauma Medicine, Naval Medical Research Unit San Antonio, Fort Sam Houston, Texas, USA.; Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, Texas, USA., Glaser JJ; Providence Regional Medical Center, Everett, Washington, USA., Weiskopf RB; Department of Anesthesia and Perioperative Medcine, University of California San Francisco, San Francisco, California, USA., Ebrahim I; Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, Western Cape, South Africa., Stassen W; Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, Western Cape, South Africa., Rambharose S; Department of Physiological Sciences, Stellenbosch University, Stellenbosch, Western Cape, South Africa., Mahoney SH; Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, Western Cape, South Africa., Wallis LA; Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, Western Cape, South Africa., Hollis EM; Naval Medical Research Unit San Antonio, Fort Sam Houston, Texas, USA., Delong GT; Naval Medical Research Unit San Antonio, Fort Sam Houston, Texas, USA., Cardin S; Naval Medical Research Unit San Antonio, Fort Sam Houston, Texas, USA.
Jazyk:	angličtina
Zdroj:	Trauma surgery & acute care open [Trauma Surg Acute Care Open] 2024 Jan 05; Vol. 9 (Suppl 1), pp. e001147. Date of Electronic Publication: 2024 Jan 05 (Print Publication: 2024).
DOI:	10.1136/tsaco-2023-001147
Abstrakt:	Objectives: Prehospital transfusion can be life-saving when transport is delayed but conventional plasma, red cells, and whole blood are often unavailable out of hospital. Shelf-stable products are needed as a temporary bridge to in-hospital transfusion. Bioplasma FDP (freeze-dried plasma) and Hemopure (hemoglobin-based oxygen carrier; HBOC) are products with potential for prehospital use. In vivo use of these products together has not been reported. This study assessed the safety of intravenous administration of HBOC+FDP, relative to normal saline (NS), in rhesus macaques (RM). Methods: After 30% blood volume removal and 30 minutes in shock, animals were resuscitated with either NS or two units (RM size adjusted) each of HBOC+FDP during 60 minutes. Sequential blood samples were collected. After neurological assessment, animals were killed at 24 hours and tissues collected for histopathology. Results: Due to a shortage of RM during the COVID-19 pandemic, the study was stopped after nine animals (HBOC+FDP, seven; NS, two). All animals displayed physiologic and tissue changes consistent with hemorrhagic shock and recovered normally. There was no pattern of cardiovascular, blood gas, metabolic, coagulation, histologic, or neurological changes suggestive of risk associated with HBOC+FDP. Conclusion: There was no evidence of harm associated with the combined use of Hemopure and Bioplasma FDP. No differences were noted between groups in safety-related cardiovascular, pulmonary, renal or other organ or metabolic parameters. Hemostasis and thrombosis-related parameters were consistent with expected responses to hemorrhagic shock and did not differ between groups. All animals survived normally with intact neurological function. Level of Evidence: Not applicable. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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