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NCT02261415 · ClinicalTrials.gov registry record · Phase 3
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial
A Phase 3 study of Cancer and Surgery, sponsored by Sunnybrook Health Sciences Centre.
- Active
- Registry status
- Phase 3
- Development phase
- 1,386
- Enrollment target
- 11
- Study locations
NCT02261415: Active Phase 3 study of Cancer and Surgery, sponsored by Sunnybrook Health Sciences Centre.
NCT02261415 is a Phase 3 study of Cancer and Surgery that is active but no longer recruiting, run by Sunnybrook Health Sciences Centre. The registered enrollment target is 1,386 participants, below the 3,489-participant average among 615 other Cancer trials with a reported enrollment target (60% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02261415, a Phase 3 study of Cancer and Surgery, is active but no longer recruiting, sponsored by Sunnybrook Health Sciences Centre.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,386 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
Receipt of one or more RBC transfusions between Day 0 and Day 7
Interventions
- DRUG Normal saline
- DRUG Tranexamic acid (TXA)
Study Locations (11)
Ontario
- Hamilton Health Sciences - Hamilton
- Kingston General Health Research Institute - Kingston
- London Health Sciences Centre - London
- Sunnybrook Health Sciences Centre - Toronto
- University Health Network - Toronto
- St. Joseph's Health Centre - Toronto
Minnesota
- Mayo Clinic - Rochester
Alberta
- Foothills Hospital - Calgary
British Colombia
- Kelowna General Hospital - Kelowna
Nova Scotia
- Queen Elizabeth II Health Sciences Centre - Halifax
Quebec
- McGill University Health Centre - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,386 participants |
| Start Date | 2014-11 |
| Est. Completion | 2027-08 |
| Phase | Phase 3 |
What the registry record for NCT02261415 still lists
NCT02261415 is an interventional study that assigns participants to a tested intervention. Its 1,386 participants enrollment target places it among the larger protocols in the corpus, below the 3,489-participant average among 615 other Cancer trials with a reported enrollment target (60% lower).
The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT02261415 lists 11 locations in 6 states (Ontario, Minnesota, Alberta).
Frequently Asked Questions
What is clinical trial NCT02261415 about?
NCT02261415 is a clinical study titled "The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial". 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 po...
What is the current status of trial NCT02261415?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,386 participants. The study started on 2014-11. Estimated completion is 2027-08.
What conditions does trial NCT02261415 study?
This clinical trial studies the following conditions: Cancer, Surgery, Tumour.
What interventions are being tested in trial NCT02261415?
The interventions under investigation include: Normal saline (DRUG), Tranexamic acid (TXA) (DRUG).
Who is sponsoring clinical trial NCT02261415?
This trial is sponsored by Sunnybrook Health Sciences Centre, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02261415 being conducted?
This trial has 11 study locations across Minnesota, Alberta, British Colombia, Nova Scotia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02261415's enrollment target sits among peer trials
1,386 73rd of 615 higher than 543 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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