| Autor: |
Mineji Hayakawa, Takashi Tagami, Daisuke Kudo, Kota Ono, Makoto Aoki, Akira Endo, Tetsuya Yumoto, Yosuke Matsumura, Shiho Irino, Kazuhiko Sekine, Noritaka Ushio, Takayuki Ogura, Sho Nachi, Yuhei Irie, Katsura Hayakawa, Yusuke Ito, Yuko Okishio, Tomohiro Muronoi, Yoshinori Kosaki, Kaori Ito, Keita Nakatsutsumi, Yutaka Kondo, Taichiro Ueda, Hiroshi Fukuma, Yuichi Saisaka, Naoki Tominaga, Takeo Kurita, Fumihiko Nakayama, Tomotaka Shibata, Shigeki Kushimoto |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
Journal of Intensive Care, Vol 11, Iss 1, Pp 1-14 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2052-0492 |
| DOI: |
10.1186/s40560-023-00682-3 |
| Popis: |
Abstract Background The efficacies of fresh frozen plasma and coagulation factor transfusion have been widely evaluated in trauma-induced coagulopathy management during the acute post-injury phase. However, the efficacy of red blood cell transfusion has not been adequately investigated in patients with severe trauma, and the optimal hemoglobin target level during the acute post-injury and resuscitation phases remains unclear. Therefore, this study aimed to examine whether a restrictive transfusion strategy was clinically non-inferior to a liberal transfusion strategy during the acute post-injury phase. Methods This cluster-randomized, crossover, non-inferiority multicenter trial was conducted at 22 tertiary emergency medical institutions in Japan and included adult patients with severe trauma at risk of major bleeding. The institutions were allocated a restrictive or liberal transfusion strategy (target hemoglobin levels: 7–9 or 10–12 g/dL, respectively). The strategies were applied to patients immediately after arrival at the emergency department. The primary outcome was 28-day survival after arrival at the emergency department. Secondary outcomes included transfusion volume, complication rates, and event-free days. The non-inferiority margin was set at 3%. Results The 28-day survival rates of patients in the restrictive (n = 216) and liberal (n = 195) strategy groups were 92.1% and 91.3%, respectively. The adjusted odds ratio for 28-day survival in the restrictive versus liberal strategy group was 1.02 (95% confidence interval: 0.49–2.13). Significant non-inferiority was not observed. Transfusion volumes and hemoglobin levels were lower in the restrictive strategy group than in the liberal strategy group. No between-group differences were noted in complication rates or event-free days. Conclusions Although non-inferiority of the restrictive versus liberal transfusion strategy for 28-day survival was not statistically significant, the mortality and complication rates were similar between the groups. The restrictive transfusion strategy results in a lower transfusion volume. Trial registration number: umin.ac.jp/ctr: UMIN000034405, registration date: 8 October 2018. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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