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

NCT02261415 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1386

Last updated 2022-10-26

No results posted yet for this 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

Interventions

DRUG

Tranexamic acid (TXA)

1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours

DRUG

Normal saline

1 g saline bolus injection + 1 g saline infusion from induction over 8 hours

Sponsors & Collaborators

  • HepatoPancreaticoBiliary (HPB) Concept Team

    collaborator UNKNOWN

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Paul Karanicolas, MD PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2022-08-31
Completion
2027-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261415 on ClinicalTrials.gov