NCT07157631 Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
| NCT ID | NCT07157631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,546 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,546 participants in total. It began in 2025-11-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. \-
Contact & Investigator
liqun yang, MD, phD
PRINCIPAL INVESTIGATOR
Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT07157631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07157631 currently recruiting?
Yes, NCT07157631 is actively recruiting participants. Contact the research team at xiaohualiu007@126.com for enrollment information.
Where is the NCT07157631 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07157631 clinical trial?
NCT07157631 is sponsored by RenJi Hospital. The principal investigator is liqun yang, MD, phD at Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 1,546 participants.