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

Launched by RENJI HOSPITAL ·

Keywords

ClinConnect Summary

This is a large, multi-center trial called ESTA (Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation). Researchers are testing whether giving a single dose of tranexamic acid (TXA) during liver transplantation can reduce blood loss in the first 24 hours after surgery, and whether TXA is at least as safe as a placebo in terms of forming blood clots in the first week after surgery. Participants would be randomly assigned to receive TXA or a matching saline placebo, and neither the patient nor the care team would know which one they got. The study plans to enroll about 1,546 adults across about 24 hospitals in China, with results expected around 2027.

Who can join? Adults age 18 and older who are scheduled for a liver transplant from another person. Key exclusions include a recent history of blood clots (in the past 3 months), having had a prior liver transplant, allergy to TXA, or being in conflicting trials. If you enroll, you would receive TXA (2 grams given through an IV within 30 minutes after the skin is opened) or the same volume of saline during the operation, in addition to standard care. You’ll be followed for several days to a month after surgery to watch for blood loss, drain output, need for blood transfusions, kidney function, and any clotting problems or other complications. The trial is overseen by a safety committee and ethics reviews, and you would sign an informed consent form before participating.

Gender

ALL

Eligibility criteria