A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation (ESTA Trial)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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Locations
Other Locations
China
Anesthesiology, Renji Hospital, Shanghai Jiao Tong university school of medicine.
RECRUITING
Shanghai
Contact Information
Primary
xiaohua liu, MD, phD
xiaohualiu007@126.com
+86 18116351197
Backup
liqun yang, MD, PHD
lqyang72721@126.com
+86 15921969001
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 1546
Treatments
Experimental: tranexamic acid group
In patients assigned to tranexamic acid, 2.0 g dissolved in 50 ml of 0.9% saline)will be given intravenously within 30 mins after skin incision.
Placebo_comparator: control group
In patients assigned to placebo, a comparable volume of 0.9% saline will be given.
Related Therapeutic Areas
Sponsors
Collaborators: Jinling Hospital, Medical School of Nanjing University, Hebei Medical University Third Hospital, The First Affiliated Hospital of University of Science and Technology of China, People's Hospital of Guangxi Zhuang Autonomous Region, Shandong First Medical University, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Huashan Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University, Fujian Medical University Union Hospital, Tongji Hospital, The First Affiliated Hospital of Anhui Medical University, The First Hospital of Jilin University, Tianjin First Central Hospital, First Affiliated Hospital of Guangxi Medical University
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov