The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial
HeLiX
1 other identifier
interventional
1,386
2 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started Nov 2014
Longer than P75 for phase_3 cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
ExpectedOctober 26, 2022
October 1, 2022
7.8 years
October 7, 2014
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Receipt of blood transfusion (% transfused): 7 days
Receipt of one or more RBC transfusions between Day 0 and Day 7
7 days
Secondary Outcomes (11)
Intraoperative blood loss
7 days
Total blood loss
7 days
Number of packed red blood cells (PRBC) units transfused
7 days
Postoperative incidence of symptomatic venous thromboembolic event
90 days
Postoperative complications assessed using Clavien-Dindo Grading System
90 days
- +6 more secondary outcomes
Study Arms (2)
Tranexamic acid (TXA)
EXPERIMENTAL1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
Normal saline (0.9% sodium chloride)
PLACEBO COMPARATOR1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
Interventions
1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Mayo Clinic
Rochester, Minnesota, United States
Foothills Hospital
Calgary, Alberta, T2N 2T9, Canada
Kelowna General Hospital
Kelowna, British Colombia, V1Y 1T2, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2YR, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8L 8E7, Canada
Kingston General Health Research Institute
Kingston, Ontario, K7L 2V7, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5, Canada
McGill University Health Centre
Montreal, Quebec, H3A 1A1, Canada
Related Publications (2)
Karanicolas 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: 39158894DERIVEDKaranicolas 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: 35210348DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Karanicolas, MD PhD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
October 10, 2014
Study Start
November 1, 2014
Primary Completion
August 1, 2022
Study Completion (Estimated)
August 1, 2027
Last Updated
October 26, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share