The Restrictive Red Blood Cell Transfusion Strategy for Critically Injured Patients (RESTRIC) trial: a cluster-randomized, crossover, non-inferiority multicenter trial of restrictive transfusion in trauma

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.

Association of initial lactate levels and red blood cell transfusion strategy with outcomes after severe trauma: a post hoc analysis of the RESTRIC trial

“…This was a post hoc analysis of the RESTRIC trial, a cluster-randomized, crossover, non-inferiority multicenter trial that was conducted across 22 institutions in Japan and involved 422 patients [ 7 ]. The design of the RESTRIC trial has been previously published [ 12 ].…”

“…To address this gap, the Restrictive Transfusion Strategy for Critically Injured Patients (RESTRIC) trial was conducted to assess the non-inferiority of a restrictive red blood cell (RBC) transfusion strategy (hemoglobin level of 7 to 9 g/dL) compared to a liberal RBC transfusion strategy (hemoglobin level of 10 to 12 g/dL) in patients experiencing potential or ongoing massive hemorrhage after trauma during the acute phase of injury [ 7 ]. The trial showed that the two groups had similar 28-day survival rates and incidences of any type of adverse event.…”

Consensus of the Brazilian association of hematology, hemotherapy and cellular therapy on patient blood management

“…In recent years, there has been increasing recognition that more restrictive transfusion thresholds may be not only safe but also beneficial in specific clinical situations. 11 , 12 , 13 , 14 , 15 , 16 , 17 …”

Schwere Blutung und Koagulopathie nach Trauma

“…ben (wobei der Hb nicht alleiniger Transfusionstrigger sein soll)[1,2]. Durch die RESTRIC-Studie wurde auch für das Trauma kein signifikanter Nachteil unter diesem restriktiven Transfusionsziel nachgewiesen[6].Eine Normothermie wird empfohlen[1,2].…”