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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• primary efficacy outcome — the initial 24 hours after study drug administration;
  Total blood loss within 24 hours of trial drug administration will be our primary efficacy outcome.
• primary safety outcome — the initial 7 postoperative days after study drug administration
  the primary safety outcome will be the incidence of a collapsed (one or more) composite of thrombotic events during the initial 7 postoperative days, including non-hemorrhagic strokes, myocardial injury after non-cardiac surgery (MINS), pulmonary embolism, hepatic artery embolism, portal vein thrombosis, bowel infarction, peripheral arterial thrombosis, symptomatic proximal venous thromboembolism.

Trial sites (1)

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