Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
Status:
NOT_YET_RECRUITING
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
NA
Details
Lead Sponsor:
RenJi Hospital
Collaborators:
First Affiliated Hospital of Guangxi Medical University First Affiliated Hospital Xi'an Jiaotong University First Affiliated Hospital, Sun Yat-Sen University Fujian Medical University Union Hospital Hebei Medical University Third Hospital Huashan Hospital Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University People's Hospital of Guangxi Zhuang Autonomous Region Second Affiliated Hospital of Guangzhou Medical University Shandong First Medical University Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University The Affiliated Hospital of Qingdao University The First Affiliated Hospital of Anhui Medical University The First Affiliated Hospital of University of Science and Technology of China The First Affiliated Hospital of Zhengzhou University The First Affiliated Hospital with Nanjing Medical University The First Hospital of Jilin University Third Affiliated Hospital, Sun Yat-Sen University Tianjin First Central Hospital Tongji Hospital Union Hospital, Tongji Medical College, Huazhong University of Science and Technology West China Hospital Zhejiang University