Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial

NCT07157631 | Recruiting DMC

• 1 other identifier: LY2025-220-C
• Study Type: interventional
• Target: 1,546
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Tranexamic Acid; End-stage Liver Disease (ESLD)

Keywords

Liver Transplantation; tranexamic acid

Outcome Measures

Primary Outcomes (2)

• primary efficacy outcome

  Total blood loss within 24 hours of trial drug administration will be our primary efficacy outcome.

  the initial 24 hours after study drug administration;

• primary safety outcome

  the primary safety outcome will be the incidence of a collapsed (one or more) composite of thrombotic events during the initial 7 postoperative days, including non-hemorrhagic strokes, myocardial injury after non-cardiac surgery (MINS), pulmonary embolism, hepatic artery embolism, portal vein thrombosis, bowel infarction, peripheral arterial thrombosis, symptomatic proximal venous thromboembolism.

  the initial 7 postoperative days after study drug administration

Secondary Outcomes (3)

• Estimated blood loss based on physician's assessment within the initial 24 hours of trial drug administration.

  within the initial 24 hours after trial drug administration

• Postoperative abdominal tube drainage volume during the initial 72 hours

  within the initial 72 hours after study drug administration

• Units of RBC transfused within 72 hours.

  within the initial 72 hours after study drug administration

Other Outcomes (7)

• The incidence of early allograft dysfunction (EAD) or primary nonfunction (PNF) within the initial 7 postoperative days.

  within the initial 7 postoperative days after study drug administration

• Acute Kidney Injury (AKI) stage within the initial 7 postoperative days as defined by KDIGO

  within the initial 7 postoperative days after study drug administration

• Surgical complications and related Clavien Dindo classification within 30 days of surgery

  30 days after study drug administration

Study Arms (2)

tranexamic acid group

EXPERIMENTAL

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.

Drug: tranexamic acid

control group

PLACEBO COMPARATOR

In patients assigned to placebo, a comparable volume of 0.9% saline will be given.

Drug: 0.9 % saline

Interventions

tranexamic acid DRUG

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.

tranexamic acid group

0.9 % saline DRUG

In patients assigned to placebo, a comparable volume of 0.9% saline will be given.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• RenJi Hospital: lead
• West China Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Huashan Hospital: collaborator
• Tianjin First Central Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Tongji Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Fujian Medical University Union Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• Zhejiang University: collaborator
• Hebei Medical University Third Hospital: collaborator
• Shandong First Medical University: collaborator
• Jinling Hospital, Medical School of Nanjing University: collaborator

Study Sites (1)

Anesthesiology, Renji Hospital, Shanghai Jiao Tong university school of medicine.

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• liqun yang, MD, phD

  Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• weifeng yu, MD, phD

  Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaohua liu, MD, phD

CONTACT

+86 18116351197; xiaohualiu007@126.com

liqun yang, MD, PHD

CONTACT

+86 15921969001; lqyang72721@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 5, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)