Impact of tranexamic acid on early allograft dysfunction following liver transplantation: study design for a prospective randomized controlled trial.

Abstract

Background: Hemorrhage and coagulation management are critical during liver transplantation (LT). Hyperfibrinolysis is a major contributor to perioperative blood loss. Tranexamic acid (TA), an antifibrinolytic agent, has been reported to reduce transfusion requirements during LT. Several studies have demonstrated that intraoperative transfusion is independently associated with early graft dysfunction (EAD), which may prolong recovery, increase sepsis incidence, and elevate mortality. However, clinical evidence regarding the prophylactic administration of TA for reducing EAD in LT remains limited. This study aims to test the hypothesis that prophylactic TA use during LT can reduce the incidence of EAD.

Methods: This is a prospective, single-center, randomized, parallel-group study. Two hundred sixty-eight adult participants scheduled for liver transplantation under general anesthesia will be included in this study. In the TA group, participants will receive a continuous infusion of TA (10 mg/kg/h) from anesthesia induction until portal vein unclamping. In the placebo group, an equivalent volume of 0.9% saline will be administered in the same manner. Anesthesia protocol will be identical in both groups and conducted according to routine clinical practice.

Discussion: To our knowledge, this is the first prospective randomized controlled trial to investigate whether prophylactic use of TA is effective in reducing EAD incidence for LT recipients.

Trial registration: This trial is registered at www.chictr.org.cn (ChiCTR2300079022). Registered on 23 December 2023.  https://www.chictr.org.cn/showproj.html?proj=215007 .