Blood component requirements in liver transplantation: effect of 2 thromboelastometry-guided strategies for bolus fibrinogen infusion, the TROMBOFIB randomized trial

Abstract

Background: A low plasma fibrinogen level influences blood component transfusion. Thromboelastometry provides clinical guidance for fibrinogen replacement in liver transplantation (LT). Objectives: We hypothesized that infusions of fibrinogen concentrate to reach an A10FIBTEM value of 11 mm during LT could reduce red blood cell (RBC) and other component and fluid requirements in comparison to standard care. Methods: This randomized, blinded, multicenter trial in 3 hospitals enrolled 189 LTscheduled patients allocated to an intervention target (A10FIBTEM, 11 mm) or a standard target (A10FIBTEM, 8 mm); 176 patients underwent LT with fibrinogen replacement. Data were analyzed by intention-to-treat (intervention group, 91; control group, 85). Blood was extracted, and fibrinogen kits were prepared to bring each patient's fibrinogen level to the assigned target at the start of LT, after portal vein clamping, and after graft reperfusion. The main outcome was the proportion of patients requiring RBC transfusion during LT or within 24 hours. Results: The proportion of patients requiring RBCs did not differ between the groups: intervention, 74.7% (95% CI, 65.5%-83.3%); control, 72.9% (95% CI, 62.2%-82.0%); absolute difference, 1.8% (95% CI, −11.1% to 14.78%) (P = .922). Thrombotic events occurred in 4% of the patients in both groups; reoperation and retransplantation rates and mortality did not differ. Nearly 70% of the patients in both groups required fibrinogen concentrate to reach the target. Using an 11-mm A10FIBTEM target increased the maximum clot firmness without affecting safety. However, this change provided no clinical benefits. Conclusion: The similar low plasma fibrinogen concentrations could explain the lack of significant between-group outcomes.