๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2022-10-25

The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial (NCT02261415)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Sunnybrook Health Sciences Centre

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic โ€” Rochester, Minnesota

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • Mayo Clinic โ€” Rochester, Minnesota
  • Foothills Hospital โ€” Calgary, Alberta
  • Kelowna General Hospital โ€” Kelowna, British Colombia
  • Queen Elizabeth II Health Sciences Centre โ€” Halifax, Nova Scotia
  • Hamilton Health Sciences โ€” Hamilton, Ontario
  • Kingston General Health Research Institute โ€” Kingston, Ontario
  • London Health Sciences Centre โ€” London, Ontario
  • Sunnybrook Health Sciences Centre โ€” Toronto, Ontario
  • University Health Network โ€” Toronto, Ontario
  • St. Joseph's Health Centre โ€” Toronto, Ontario
  • McGill University Health Centre โ€” Montreal, Quebec

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 664-4580

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—