Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
Sabate A, Gutierrez R, et al.American Journal of Transplantation 2016; 16(8): 2421-2429.
Aims
To test whether pre-emptive administration of concentrated fibrinogen in liver transplantation (LT) patients with a low preoperative plasma fibrinogen level would reduce requirements for blood product.
Interventions
Participants were randomly allocated to receive either fibrinogen versus saline.
Participants
99 patients scheduled for LT aged 18–80 years.
Outcomes
The primary outcome measured was the percentage of patients requiring transfusion of packed red blood cells (RBCs) during the procedure. Secondary measured outcomes included percentage of patients requiring fresh frozen plasma, fibrinogen concentrate and platelets, number of units of packed RBCs, fresh frozen plasma and platelets transfused, grams of fibrinogen administered, number of patients and grams of tranexamic acid administered, mortality, liver graft survival, and thrombotic complications.
Follow-up
30 days
CET Conclusions
This well-designed multicentre double-blind RCT randomised liver transplant recipients to pre-emptive fibrinogen or saline placebo at the time of transplantation. The study was halted after a pre-planned interim analysis demonstrated futility with no evidence of effect on blood transfusion requirement, despite higher plasma fibrinogen levels in the treatment arm. There appeared to be no adverse events related to fibrinogen administration in the randomised patients. It is of note that more patients in the placebo arm required fibrinogen after graft reperfusion, suggesting that active management on reperfusion with appropriate use of fibrinogen at this stage is as effective as pre-emptive use. Transfusion rates in both arms of the study (around 50% patients) were significantly lower than those anticipated in the sample size calculation (80%).
Data analysis
Strict intention-to-treat analysis
Trial registration
EudraCT - 2010-024584; ClinicalTrials.gov - NCT01539057