Trial · NCT07157631
Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
NCT07157631, Not applicable, Recruiting, RenJi Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial. Trials, record NCT07157631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07157631
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
- NCT number
- NCT07157631
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 1,546 participants, estimated
- Lead sponsor
- RenJi Hospital
- Conditions
- Liver Transplantation, Tranexamic Acid, End-stage Liver Disease (ESLD)
- Interventions
- tranexamic acid, 0.9 % saline
- First posted
- 2025-09-05
- Last updated
- 2025-12-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | primary efficacy outcome | the initial 24 hours after study drug administration; | Total blood loss within 24 hours of trial drug administration will be our primary efficacy outcome. |
| Primary | primary safety outcome | the initial 7 postoperative days after study drug administration | 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. |
| Secondary | 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 | Estimated loss will be recorded by the attending anesthesiologist who collect blood loss at the end of surgery by adding the blood volume recovered in the suction canisters, and the sponges (by weighing surgical sponges before and after surgical use), and then subtracted the irrigation fluid, lymph, bile, serum, ascites, urine, and other fluids solution volumes, and finally add the postoperative drainage volume in the intensive care unit. |
| Secondary | Postoperative abdominal tube drainage volume during the initial 72 hours | within the initial 72 hours after study drug administration | The cumulative volume of fluid collected from the intra-abdominal drainage tube(s) placed during liver transplantation. Drainage will be measured and recorded at regular intervals for the first 72 hours after study drug administration. The total amount (in milliliters) over this 72-hour period will be recorded. |
| Secondary | Units of RBC transfused within 72 hours. | within the initial 72 hours after study drug administration | RBC transfusion will be based on clinical need, but generally initiated when intraoperative hemoglobin is less than 70 g/L\[40\]. |
| Other | 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 | EAD is defined according to Olthoff's criteria as one of the following: (a) bilirubin ≥ 10 mg/dL on day 7; or (b) INR ≥ 1.6 on day 7; or (c) AST/ ALT \> 2000 IU/L within first 7 days. PNF is defined as graft loss, re-transplantation, or patient death due to graft non-function in first 30 days (excluding non-function secondary to hepatic artery thrombosis, biliary complications, or recurrent hepatic disease). |
| Other | 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 | The stages of Acute Kidney Injury (AKI) within first 7 days which is defined according to KDIGO (Kidney Disease Improving Global Outcomes criteria\[33\]: Stage 1 (a) increase in SCr by 0.3 mg/dl within any 48-hour window; or (b) increase in SCr to 1.5 times of baseline within the past 7 days; or (c) urine output less than 0.5 ml/kg/h for 6 hours. Stage 2 (a) increase in SCr to 2.0 times of baseline within the past 7 days; (b) urine output less than 0.5 ml/kg/hour for more than 12 hours. |
| Other | Surgical complications and related Clavien Dindo classification within 30 days of surgery | 30 days after study drug administration | |
| Other | Total hours of mechanical ventilation after surgery | 30 days after study drug administration | |
| Other | Total hours in an ICU after surgery | 30 days after study drug administration |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07157631
GET https://conductscience.org/api/trials/v1/NCT07157631/registered