Testing Tranexamic Acid Versus Placebo to Reduce Bleeding and Ensure Safety in Adults Undergoing Liver Transplant Surgery

What this Trial Is About

Researchers are conducting a multi-center randomized trial to evaluate tranexamic acid compared to placebo in adult patients undergoing orthotopic liver transplantation. The study aims to test if tranexamic acid reduces blood loss within the first 24 hours after surgery and to assess its safety by examining thrombotic events in the first 7 postoperative days. Additionally, the trial will explore whether tranexamic acid affects total drainage volume and blood transfusion needs within the first 3 days after transplantation. Participants will be randomly assigned to receive either 2.0 g of tranexamic acid dissolved in 50 ml of saline intravenously within 30 minutes after the skin incision or a matching volume of saline as placebo. The trial uses a double-blind design to ensure that patients, surgeons, anesthesiologists, and postoperative interviewers do not know the group assignments. The study plans to enroll 1546 patients from multiple centers and follow them through the early postoperative period. During the study, participants will receive routine surgical, anesthesia, and perioperative care. Researchers will collect detailed data before, during, and after surgery, including laboratory tests, imaging results, and intraoperative measurements such as blood loss and transfusion volumes. The main outcomes measured are blood loss within 24 hours and thrombotic events within 7 days after drug administration, along with secondary outcomes like postoperative drainage and red blood cell transfusions within 72 hours. Safety and efficacy will be closely monitored throughout the trial.

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