Tranexamic acid to reduce bleeding in adult liver transplant
A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation (ESTA Trial)
This will test whether giving tranexamic acid during adult liver transplant reduces blood loss in the first 24 hours and does not increase clotting in the first week.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1546 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07157631 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, placebo-controlled trial enrolling adults undergoing orthotopic liver transplantation. Participants are randomized to 2.0 g intravenous tranexamic acid at the start of surgery or matching saline placebo. The co-primary hypotheses are that tranexamic acid is superior to placebo for reducing blood loss within 24 hours and non-inferior for a composite of thrombotic events within 7 postoperative days. Secondary endpoints include postoperative drainage volume and blood transfusion requirements within three days. The study plans to randomize 1,546 patients to provide 80% power for the safety (non-inferiority) endpoint and excludes patients with recent thrombosis, re-transplantation, tranexamic acid allergy, or those judged unsuitable by the care team.
Who should consider this trial
Good fit: Consenting adults (age ≥18) scheduled for allogeneic orthotopic liver transplantation under general anesthesia who do not meet the exclusion criteria.
Not a fit: Patients with arterial or venous thrombosis within the prior 3 months, those undergoing re-transplantation, people with known tranexamic acid allergy, or those judged unsuitable by their surgeon or anesthesiologist are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, this could lower perioperative blood loss and reduce the need for transfusions after liver transplant without increasing short-term clotting risk.
How similar studies have performed: Tranexamic acid has reduced bleeding in many types of surgery and smaller liver transplant series have suggested benefit, but large randomized safety data in liver transplantation have been limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:consenting adults aged at least 18 years who are scheduled for allogeneic liver transplantation with general anesthesia. \- Exclusion Criteria:1) 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. \-
Where this trial is running
Shanghai, Shanghai Municipality
- Anesthesiology, Renji Hospital, Shanghai Jiao Tong university school of medicine. — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: liqun yang, MD, phD — Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: xiaohua liu, MD, phD
- Email: xiaohualiu007@126.com
- Phone: +86 18116351197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.