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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.

Abstract Background The management of cervical spinal cord injury (SCI) has changed drastically in the last decades, and surgery is the primary treatment. However, the optimum timing of early surgical treatment (within 24 h or 72 h after injury) is still controversial. We sought to determine the optimum timing of surgery for cervical SCI, comparing the length of the intensive care unit (ICU) stay and in-hospital mortality in patients who underwent surgical treatments (decompression and stabilization) for cervical SCI within 24 h after injury and within 7 days after injury. Methods This was a retrospective cohort study using Japan Trauma Data Bank (JTDB) which is a nationwide, multicenter database. We selected adult isolated cervical SCI patients who underwent operative management within 7 days after injury, between 2004 and 2015. The main outcome measures were the length of ICU stay and in-hospital mortality. We grouped the patients into two, based on the time from onset of injury to surgery, an early group (within 24 h) and a late group (from 25 h to 7 days). Next, we performed multivariable analyses for analyzing the relevance between the timing of surgery and the length of ICU stay after adjusting for baseline characteristics using propensity score. We also performed the Cox survival analyses to evaluate in-hospital mortality. Results From 236,698 trauma patients registered in JTDB, we analyzed 514 patients. The early group comprised 291 patients (56.6%), and the late group comprised 223 (43.4%). The length of ICU stay did not differ between the two groups (early, 10 days; late, 11 days; p = 0.29). There was no significant difference for length of ICU stay between the early and late group even after adjustment by multivariate analysis (p = 0.64). There was no significant difference in in-hospital mortality between the two groups (the early group 3.8%, the late group 2.2%, p = 0.32), and no significant difference was found in the Cox survival analysis. Conclusions Our study showed that neither the length of ICU stay nor in-hospital mortality after spinal column stabilization or spinal cord decompression for cervical SCI significantly differed according to the timing of surgery between 24 h and 7 days.