Whole blood transfusion in the treatment of acute hemorrhage, a systematic review and meta-analysis.

BACKGROUND: Whole blood (WB) transfusion received renewed interest after recent armed conflicts. The effectiveness as compared with blood component transfusion (BCT) is, however, still topic of debate. Therefore, this study investigated the effect of WB ± BCT as compared with BCT transfusion on survival in trauma patients with acute hemorrhage. METHODS: Studies published up to January 16, 2023, including patients with traumatic hemorrhage comparing WB ± BCT and BCT were included in meta-analysis. Subanalyses were performed on the effectiveness of WB in the treatment of civilian or military trauma patients, patients with massive hemorrhage and on platelet (PLT)/red blood cell (RBC), plasma/RBC and WB/RBC ratios. Methodological quality of studies was interpreted using the Cochrane risk of bias tool. The study protocol was registered in PROSPERO under number CRD42022296900. RESULTS: Random effect pooled odds ratio (OR) for 24 hours mortality in civilian and military patients treated with WB as compared with BCT was 0.72 (95% confidence interval [CI], 0.53-0.97). In subanalysis of studies conducted in civilian setting (n = 20), early (4 hours, 6 hours, and emergency department) and 24 hours mortality was lower in WB groups compared with BCT groups (OR, 0.65; 95% CI, 0.44-0.96 and OR, 0.71; 95% CI, 0.52-0.98). No difference in late mortality (28 days, 30 days, in-hospital) was found. In military settings (n = 7), there was no difference in early, 24 hours, or late mortality between groups. The WB groups received significant higher PLT/RBC ( p = 0.030) during early treatment and significant higher PLT/RBC and plasma/RBC ratios during 24 hours of treatment ( p = 0.031 and p = 0.007). The overall risk of bias in the majority of studies was judged as serious due to serious risk on confounding and selection bias, and unclear information regarding cointerventions. CONCLUSION: Civilian trauma patients with acute traumatic hemorrhage treated with WB ± BCT as compared to BCT had lower odds on early and 24-hour mortality. In addition, WB transfusion resulted in higher PLT/RBC and plasma/RBC ratios. LEVEL OF EVIDENCE: Systematic Review and Meta-Analysis; Level III.

The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding: MAFOD-study protocol for a randomized controlled non-inferiority trial.

BACKGROUND: The Netherlands Armed Forces have been successfully using deep-frozen (- 80 °C) thrombocyte concentrate (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for the effectiveness and safety of DTCs is currently lacking. Therefore, the MAssive transfusion of Frozen bloOD (MAFOD) trial is designed to compare the haemostatic effect of DTCs versus room temperature-stored platelets (RSP) in the treatment of surgical bleeding. METHODS: The MAFOD trial is a single-blinded, randomized controlled non-inferiority trial and will be conducted in three level 1 trauma centres in The Netherlands. Patients 12 years or older, alive at hospital presentation, requiring a massive transfusion including platelets and with signed (deferred) consent will be included. The primary outcome is the percentage of patients that have achieved haemostasis within 6 h and show signs of life. Haemostasis is defined as the time in minutes from arrival to the time of the last blood component transfusion (plasma/platelets or red blood cells), followed by a 2-h transfusion-free period. This is the first randomized controlled study investigating DTCs in trauma and vascular surgical bleeding. DISCUSSION: The hypothesis is that the percentage of patients that will achieve haemostasis in the DTC group is at least equal to the RSP group (85%). With a power of 80%, a significance level of 5% and a non-inferiority limit of 15%, a total of 71 patients in each arm are required, thus resulting in a total of 158 patients, including a 10% refusal rate. The data collected during the study could help improve the use of platelets during resuscitation management. If proven non-inferior in civilian settings, frozen platelets may be used in the future to optimize logistics and improve platelet availability in rural or remote areas for the treatment of (massive) bleeding trauma patients in civilian settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05502809. Registered on 16 August 2022.