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ACTIVE NOT RECRUITING Phase 3

The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial

NCT02261415 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

FieldValue
Enrollment Target 1,386 participants
Start Date 2014-11
Est. Completion 2027-08
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02261415

The ClinicalTrials.gov registry entry for NCT02261415 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,386 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sunnybrook Health Sciences Centre, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02261415 reports 11 study locations spanning 6 distinct geographic areas — top geographies include Ontario, Minnesota, Alberta. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02261415?

The interventions under investigation include: Normal saline (DRUG), Tranexamic acid (TXA) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02261415?

This trial is sponsored by Sunnybrook Health Sciences Centre, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial