Actively Recruiting
Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
Led by RenJi Hospital · Updated on 2025-12-08
1546
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
consenting adults aged at least 18 years who are scheduled for allogeneic liver transplantation with general anesthesia.
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You will not qualify if you...
- History of arterial or venous thrombosis within 3 months; 2) Re-transplantation; 3) Known allergy to tranexamic acid; 4) Participation in potentially conflicting clinical trials; 5) Considered by the responsible surgeon or anesthesiologist to be unsuitable.
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Trial Site Locations
Total: 1 location
1
Anesthesiology, Renji Hospital, Shanghai Jiao Tong university school of medicine.
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
X
xiaohua liu, MD, phD
CONTACT
L
liqun yang, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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