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Background Hemorrhage is the most common cause of potentially preventable death after injury. Balanced transfusion with red blood cells, plasma, and platelets (component therapy, CT) has been shown to reduce mortality, and is the standard of care. Low-Titer Group O Whole Blood (LTOWB) is an attractive alternative to CT, but existing evidence comprises observational studies, and a small single center pilot randomized controlled trial, which evaluated a type of whole blood that is no longer in use. The aim of the “Trauma Resuscitation with Low-Titer Group O Whole Blood Or Products” (TROOP) trial is to compare the effectiveness and safety of LTOWB and CT in critically injured patients predicted to require a large volume transfusion. Methods This is a pragmatic, multicenter, Bayesian, sequential non-inferiority/superiority, randomized clinical trial, performed within 15 level I trauma centers in the United States. We aim to randomize 1,100 injured patients to resuscitation with either CT or LTOWB. The primary outcome is 6-h mortality. Secondary outcomes include 24-h and 30-day or hospital mortality (whichever is earlier); prespecified complications; adjudicated cause of death; time to death; length of stay (ICU and hospital); and hospital-, ventilator- and ICU-free days; the incidence of major surgical procedures; time to hemostasis in those undergoing procedures with a hemostatic component; number and type of blood products used until hemostasis is achieved (and randomized products are discontinued), as well as after hemostasis has been achieved, to 24 h post-admission; discharge destination and functional status and quality of life at hospital discharge or 30 days, as measured by Glasgow Coma Scale (GCS) and EuroQol (EQ-5D) quality of life measurement. Discussion This large multicenter clinical trial will contribute high-level evidence on the effectiveness of Low-Titer Group O Whole Blood in the in-hospital management of trauma patients predicted to require a large volume transfusion. Trial registration National Clinical Trial Identified Number: NCT05638581. Clinical trial registry: https://clinicaltrials.gov/study/NCT05638581 First submitted 2022–11-08.

Background Early balanced transfusion is associated with improved outcome in haemorrhagic shock patients. This study describes the implementation and evaluates the safety of a whole blood transfusion program in a civilian helicopter emergency medical service (HEMS). Methods This prospective observational study was performed over a 5-year period at HEMS-Bergen, Norway. Patients in haemorrhagic shock receiving out of hospital transfusion of low-titre Group O whole blood (LTOWB) or other blood components were included. Two LTOWB units were produced weekly and rotated to the HEMS for forward storage. The primary endpoints were the number of patients transfused, mechanisms of injury/illness, adverse events and survival rates. Informed consent covered patient pathway from time of emergency interventions to last endpoint and subsequent data handling/storage. Results The HEMS responded to 5124 patients. Seventy-two (1.4%) patients received transfusions. Twenty patients (28%) were excluded due to lack of consent (16) or not meeting the inclusion criteria (4). Of the 52 (100%) patients, 48 (92%) received LTOWB, nine (17%) received packed red blood cells (PRBC), and nine (17%) received freeze-dried plasma. Of the forty-six (88%) patients admitted alive to hospital, 35 (76%) received additional blood transfusions during the first 24 h. Categories were blunt trauma 30 (58%), penetrating trauma 7 (13%), and nontrauma 15 (29%). The majority (79%) were male, with a median age of 49 (IQR 27–70) years. No transfusion reactions, serious complications or logistical challenges were reported. Overall, 36 (69%) patients survived 24 h, and 28 (54%) survived 30 days. Conclusions Implementing a whole blood transfusion program in civilian HEMS is feasible and safe and the logistics around out of hospital whole blood transfusions are manageable. Trial registration The study is registered in the ClinicalTrials.gov registry (NCT02784951).

Purpose Hemorrhage is a significant cause of trauma-related death. Low-titer O-positive whole blood (LTOWB) is an alternative to component therapy (CT) [packed red blood cells (PRBC) and fresh frozen plasma (FFP)]. We evaluated if LTOWB reduces transfusion requirement or mortality. Methods Adult male trauma activations requiring uncrossmatched transfusion in the emergency department underwent nonblinded 24-hour block randomization to receive uncrossmatched LTOWB or CT in the emergency department (ED). Female patients, children, and known prisoners were excluded. If LTOWB was not available, CT was used. Primary outcome was transfusion requirement in patients surviving ≥ 24 h, with a subset analysis for patients undergoing hemorrhage control interventions (HCI). Dichotomous variables were evaluated with Chi-Square testing and continuous outcomes with Student’s T-test. Results Overall, 199 patients were randomized (52 LTOWB, 147 CT); 36 patients (12 LTOWB, 24 CT) were excluded post-randomization for mortality within 24 h. The remaining 40 LTOWB and 123 CT patient cohorts had similar age, Glasgow Coma Scale, Injury Severity Score, heart rate, systolic blood pressure, and temperature. LTOWB patients received 1.4 ± 0.75 LTOWB units. LTOWB patients trended toward less transfusion (PRBC [3.8 ± 5.6 vs. 5.7 ± 6.2 units, p  = 0.077], FFP [2.3 ± 3.8 vs. 3.5 ± 4.3 units, p  = 0.088], and CRYO [0.13 ± 0.34 vs. 0.28 ± 0.68 units, p  = 0.061]). Mortality was similar (LTOWB:10.2% [4/39] vs. CT:10.5% [13/123], p  = 0.956). LTOWB patients undergoing HCI had less transfusion than CT patients (PRBC [3.9 ± 5.1 vs. 7.4 ± 7.2 units, p  = 0.013]; in the HCI cohort the differences were even more pronounced when severe traumatic brain injury (TBI) deaths were excluded (PRBC [3.0 ± 3.6 vs. 7.4 ± 7.2 units, p  < 0.001], FFP [2.1 ± 2.3 vs. 4.5 ± 5.2 units, p  = 0.005]). Conclusion LTOWB is associated with reduced PRBC transfusion in patients undergoing HCI, and a trend toward decreased PRBC, FFP, and CRYO transfusion in all patients. Trial registration ClinicalTrials.gov (NCT05081063), posted 10/18/2021.