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Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
Sponsor: RenJi Hospital
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.
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation (ESTA Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1546
Start Date
2025-11-01
Completion Date
2027-12-01
Last Updated
2025-12-08
Healthy Volunteers
No
Interventions
tranexamic acid
In patients assigned to tranexamic acid, 2.0 g dissolved in 50 ml of 0.9% saline）will be given intravenously within 30 mins after skin incision.
0.9 % saline
In patients assigned to placebo, a comparable volume of 0.9% saline will be given.
Locations (1)
Anesthesiology, Renji Hospital, Shanghai Jiao Tong university school of medicine.
Shanghai, Shanghai Municipality, China