Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial

We propose a multi-center randomized trial to test the primary hypothesis that tranexamic acid is superior to placebo on blood loss in adult orthotopic liver transplantation within the initial 24 hours and that tranexamic acid is non-inferior to placebo for a composite of thrombotic events within the initial 7 postoperative days. Secondarily, we will determine whether tranexamic acid is superior to placebo on total postoperative drainage volume and blood product transfusion within the initial 3 postoperative days. We propose to randomize patients to 2.0 g of tranexamic acid intravenously at the start of surgery or a comparable volume of 0.9% normal saline placebo. Because demonstrating safety will require more patients, our sample size is based on safety. Randomizing 1546 patients will provide 80% power for detecting a non-inferiority margin of 4% with a baseline incidence of 10% for composite thrombotic events within the initial 7 postoperative days.

NCT Number	NCT07157631
Lead Sponsor	RenJi Hospital Collaborators: West China Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University, Huashan Hospital, Tianjin First Central Hospital, The First Hospital of Jilin University, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University, Tongji Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, The First Affiliated Hospital of University of Science and Technology of China, The First Affiliated Hospital of Anhui Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital Xi'an Jiaotong University, Fujian Medical University Union Hospital, First Affiliated Hospital of Guangxi Medical University, Second Affiliated Hospital of Guangzhou Medical University, Zhejiang University, Hebei Medical University Third Hospital, Shandong First Medical University, Jinling Hospital, Medical School of Nanjing University
Conditions	Liver Transplantation, Tranexamic Acid, End-stage Liver Disease (ESLD)
Enrollment	1,546 participants
Start Date	2025-11-01
Primary Completion	2027-11-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-08