Actively Recruiting
Efficacy and Safety of Tranexamic Acid Compared to Placebo in Adult Liver Transplantation A Double-Blind, Randomized, Multi-Center Trial (ESTA Trial)
Led by RenJi Hospital · Updated on 2025-12-08
1546
Participants Needed
1
Research Sites
4 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
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.
CONDITIONS
Brief Title
Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged at least 18 years
- Scheduled for allogeneic liver transplantation
- Receiving general anesthesia
- Able to provide informed consent
You will not qualify if you...
- History of arterial or venous thrombosis within the past 3 months
- Undergoing liver re-transplantation
- Known allergy to tranexamic acid
- Currently participating in conflicting clinical trials
- Considered unsuitable by the responsible surgeon or anesthesiologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Surgery day and initial 3 postoperative days
Participants receive either tranexamic acid or placebo intravenously during liver transplantation surgery and are monitored during the perioperative period.
1 surgery visit and daily assessments for up to 3 days post-surgery
Duration - 7 days
Participants are monitored for safety outcomes including thrombotic events during the first 7 days after surgery.
Daily visits or assessments for 7 days post-surgery
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
L
liqun yang, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here