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NCT07157631: ESTA
Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial
NA trial testing tranexamic acid in Liver Transplantation in 1,546 participants. Currently enrolling.
1 November 2027
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 1,546 |
| Start date | 1 November 2025 |
| Primary completion | 1 November 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- tranexamic acid (Tranexamic Acid) — full drug profile →
- 0.9 % saline
Conditions studied
- Liver Transplantation — all drugs for Liver Transplantation →
- Tranexamic Acid — all drugs for Tranexamic Acid →
- End-stage Liver Disease (ESLD) — all drugs for End-stage Liver Disease (ESLD) →
Sponsor
RenJi Hospital
Who can join
18 and older, any sex, with Liver Transplantation or Tranexamic Acid. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07157631
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of tranexamic acid
Trials testing the same drug.
- NCT06457360 — Comparison of Chitosan, Ankaferd and Tranexamic Acid in Dental Extraction in Liver Pre-Transplant Children · EARLY_PHASE1 · completed
- NCT05053867 — A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients · Phase 3 · recruiting
- NCT04625530 — Perioperative Management in Gynaecological Carcinoma Surgery · Phase 3 · withdrawn
- NCT04419246 — The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy · NA · unknown
- NCT03963466 — A Clinical Observation of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma. · NA · completed
Other recruiting trials for Liver Transplantation
Currently open trials in the same condition.
- NCT07123740 — Comparison of the Postoperative Analgesic Effects of ITM and Bi-level ESPB in Liver Transplantation Donors · NA · recruiting
- NCT06717919 — HOPE Against Cancer Recurrence in HCC · Phase 4 · recruiting
- NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant · Phase 4 · active not recruiting
- NCT06874296 — Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time · NA · recruiting
- NCT06354179 — Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Live · Phase 4 · recruiting
Other RenJi Hospital trials
Trials by the same sponsor.
- NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
- NCT07537725 — EEG-TMS for Postoperative Delirium After Cardiac Surgery · NA · not yet recruiting
- NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
- NCT07343076 — Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE · NA · not yet recruiting
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07157631 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RenJi Hospital
- Last refreshed: 8 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07157631.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing