Transfusion requirements after head trauma: a randomized feasibility controlled trial

BackgroundAnemia is frequent among patients with traumatic brain injury (TBI) and is associated with an increased risk of poor outcome. The optimal hemoglobin concentration to trigger red blood cell (RBC) transfusion in patients with TBI is not clearly defined.MethodsAll eligible consecutive adult patients admitted to the intensive care unit (ICU) with moderate or severe TBI were randomized to a restrictive (hemoglobin transfusion threshold of 7g/dL), or a liberal (threshold 9g/dL) transfusion strategy. The transfusion strategy was continued for up to 14days or until ICU discharge. The primary outcome was the mean difference in hemoglobin between groups. Secondary outcomes included transfusion requirements, intracranial pressure management, cerebral hemodynamics, length of stay, mortality and 6-month neurological outcome.ResultsA total of 44 patients were randomized, 21 patients to the liberal group and 23 to the restrictive group. There were no baseline differences between the groups. The mean hemoglobin concentrations during the 14-day period were 8.41.0 and 9.31.3 (p<0.01) in the restrictive and liberal groups, respectively. Fewer RBC units were administered in the restrictive than in the liberal group (35 vs. 66, p=0.02). There was negative correlation (r=-0.265, p<0.01) between hemoglobin concentration and middle cerebral artery flow velocity as evaluated by transcranial Doppler ultrasound and the incidence of post-traumatic vasospasm was significantly lower in the liberal strategy group (4/21, 3% vs. 15/23, 65%; p<0.01). Hospital mortality was higher in the restrictive than in the liberal group (7/23 vs. 1/21; p=0.048) and the liberal group tended to have a better neurological status at 6months (p=0.06).Conclusions The trial reached feasibility criteria. The restrictive group had lower hemoglobin concentrations and received fewer RBC transfusions. Hospital mortality was lower and neurological status at 6 months favored the liberal group.Trial registration ClinicalTrials.gov, NCT02203292. Registered on 29 July 2014.