Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
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
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- tranexamic acid
- 0.9 % saline
Treatment groups
1,546 Participants
are divided into 2 treatment groupsSponsors and collaborators
RenJi Hospital
Lead sponsor
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
Source ClinicalTrials.gov