Status:
ACTIVE_NOT_RECRUITING
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
HepatoPancreaticoBiliary (HPB) Concept Team
Conditions:
Cancer
Tumour
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 rationa...
Detailed Description
Purpose Compelling biological rationale and indirect evidence from other settings suggest that there is potential benefit to administering TXA to patients undergoing liver resection. A lack of consens...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
1386 Patients enrolled
Trial Details
Trial ID
NCT02261415
Start Date
November 1 2014
End Date
August 1 2027
Last Update
October 26 2022
Active Locations (11)
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1
Mayo Clinic
Rochester, Minnesota, United States
2
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
3
Kelowna General Hospital
Kelowna, British Colombia, Canada, V1Y 1T2
4
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2YR