Clinical trial · Interventional
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial: Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. The sample size for this study is 1230 participants.Participants enrolled in the prior Vanguard study will proceed directly into the RCT.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
| Tumour | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal saline | Drug | — | UNRESOLVED |
| Tranexamic acid (TXA) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tranexamic acid (TXA)
- description
- 1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
- interventionNames
- Drug: Tranexamic acid (TXA)
- type
- PLACEBO_COMPARATOR
- label
- Normal saline (0.9% sodium chloride)
- description
- 1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
- interventionNames
- Drug: Normal saline
Primary outcomes (1)
- measure
- Receipt of blood transfusion (% transfused): 7 days
- timeFrame
- 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient scheduled for open or laparoscopic liver surgery * Age ≥18 years * Cancer related diagnosis or indication (e.g. pre-cancer, suspicion of cancer, definite cancer) Exclusion Criteria: * Severe anemia (hemoglobin (Hgb) levels \<90 g/l) * Documented arterial or venous thrombosis at screening or in past three months (not including therapeutic portal vein embolization) * Anticoagulants (other than low-molecular-weight heparin (LMWH) or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week * Known disseminated intravascular coagulation * Severe renal insufficiency (creatinine clearance (CrCl) \<30 ml/min) * History of seizure disorder * Pregnant or lactating (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation) * Acquired disturbance of colour vision * Hypersensitivity to TXA or any of the ingredients * Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction) * Previously enrolled in this study
References
Publications (2)
- DERIVEDKaranicolas PJ, Lin Y, McCluskey SA, Tarshis J, Thorpe KE, Wei A, Dixon E, Porter G, Chaudhury P, Nanji S, Ruo L, Tsang ME, Skaro A, Eeson G, Cleary S, Moulton CA, Ball CG, Hallet J, Coburn N, Serrano PE, Jayaraman S, Law C, Tandan V, Sapisochin G, Nagorney D, Quan D, Smoot R, Gallinger S, Metrakos P, Reichman TW, Jalink D, Bennett S, Sutherland F, Solano E, Molinari M, Tang ES, Warner SG, Bathe OF, Barkun J, Kendrick ML, Truty M, Roke R, Xu G, Lafreniere-Roula M, Guyatt G; HPB CONCEPT Team. Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial. JAMA. 2024 Oct 1;332(13):1080-1089. doi: 10.1001/jama.2024.11783. PMID 39158894
- DERIVEDKaranicolas PJ, Lin Y, McCluskey S, Roke R, Tarshis J, Thorpe KE, Ball CG, Chaudhury P, Cleary SP, Dixon E, Eeson G, Moulton CA, Nanji S, Porter G, Ruo L, Skaro AI, Tsang M, Wei AC, Guyatt G; HepatoPancreaticoBiliary Community of Surgical ONcologists: Clinical, Evaluative, and Prospective Trials (HPB CONCEPT) Team. Tranexamic acid versus placebo to reduce perioperative blood transfusion in patients undergoing liver resection: protocol for the haemorrhage during liver resection tranexamic acid (HeLiX) randomised controlled trial. BMJ Open. 2022 Feb 24;12(2):e058850. doi: 10.1136/bmjopen-2021-058850. PMID 35210348