1.
Blood component requirements in liver transplantation: effect of 2 thromboelastometry-guided strategies for bolus fibrinogen infusion-the TROMBOFIB randomized trial
Caballero, M., Sabate, A., Gutierrez, R., Beltran, J., Pérez, L., Pujol, R., Viguera, L., Costa, M., Reyes, R., Martinez, A., et al
Journal of Thrombosis and Haemostasis : Jth. 2023;21(1):37-46
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 A10(FibTem) 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 LT-scheduled patients allocated to an intervention target (A10(FibTem), 11 mm) or a standard target (A10(FibTem), 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 A10(FibTem) 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.
2.
Impact of pre-emptive fibrinogen concentrate on transfusion requirements in liver transplantation: a multicenter, randomized, double-blind, placebo-controlled trial
Sabate A, Gutierrez R, Beltran J, Mellado P, Blasi A, Acosta F, Costa M, Reyes R, Torres F
American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2016;16((8):):2421-9
Abstract
We hypothesized that pre-emptive fibrinogen administration to obtain an initial plasma level of 2.9 gm/L would reduce transfusion requirements in liver transplantation. A randomized, multicenter, hemoglobin-stratified, double-blind, fibrinogen versus saline-controlled trial was conducted. The primary endpoint was the percentage of patients requiring red blood cells. We evaluated 51 patients allocated to fibrinogen and 48 to saline; the primary endpoint was assessed using data for 92 patients because the electronic record form were offline for three patients in the fibrinogen group and four in the saline group. We injected a median of 3.54 gm of fibrinogen pre-emptively in the fibrinogen group. Nine patients in the saline group (20.9%) required fibrinogen at graft reperfusion (versus one patient [2.1%] in the fibrinogen group; p= 0.005). Blood was transfused to 52.9% (95% CI 42.5% to 63.3%) in the fibrinogen group and 42.74% (95% CI 28.3% to 57.2%) in the saline group (p=0.217). Relative risk for blood transfusion was 0.80 (95% CI 0.57 to 1.13). Thrombotic events occurred in 1 (2.1%) and 5 (11.4%) in the fibrinogen and saline groups, respectively. Seven (14.6%) in the fibrinogen and 9 (20.3%) in the saline group, required reoperation. Pre-emptive administration of fibrinogen concentrate did not influence transfusion requirements. This article is protected by copyright. All rights reserved.