Tranexamic acid to reduce bleeding in adult liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:consenting adults aged at least 18 years who are scheduled for allogeneic liver transplantation with general anesthesia.

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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.

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Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.