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

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)

Interventions

DRUG

tranexamic acid

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

0.9 % saline

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

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Tianjin First Central Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• The First Affiliated Hospital of University of Science and Technology of China

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Hebei Medical University Third Hospital

  collaborator OTHER

• Shandong First Medical University

  collaborator OTHER

• Jinling Hospital, Medical School of Nanjing University

  collaborator UNKNOWN

• RenJi Hospital

  lead OTHER

Principal Investigators

• liqun yang, MD, phD · Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

• weifeng yu, MD, phD · Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2027-11-01

Completion

2027-12-01

Countries

• China

Study Locations