Tranexamic acid versus placebo to reduce perioperative blood transfusion in patients undergoing liver resection: Protocol for the haemorrhage during liver resection tranexamic acid (HeLiX) randomised controlled trial

Paul Jack Karanicolas, Yulia Lin, Stuart McCluskey, Rachel Roke, Jordan Tarshis, Kevin E. Thorpe, Chad G. Ball, Prosanto Chaudhury, Sean P. Cleary, Elijah Dixon, Gareth Eeson, Carol Anne Moulton, Sulaiman Nanji, Geoff Porter, Leyo Ruo, Anton I. Skaro, Melanie Tsang, Alice C. Wei, Gordon Guyatt

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

Introduction Despite use of operative and non-operative interventions to reduce blood loss during liver resection, 20%-40% of patients receive a perioperative blood transfusion. Extensive intraoperative blood loss is a major risk factor for postoperative morbidity and mortality and receipt of blood transfusion is associated with serious risks including an association with long-term cancer recurrence and overall survival. In addition, blood products are scarce and associated with appreciable expense; decreasing blood transfusion requirements would therefore have health system benefits. Tranexamic acid (TXA), an antifibrinolytic, has been shown to reduce the probability of receiving a blood transfusion by one-third for patients undergoing cardiac or orthopaedic surgery. However, its applicability in liver resection has not been widely researched. Methods and analysis This protocol describes a prospective, blinded, randomised controlled trial being conducted at 10 sites in Canada and 1 in the USA. 1230 eligible and consenting participants will be randomised to one of two parallel groups: experimental (2 g of intravenous TXA) or placebo (saline) administered intraoperatively. The primary endpoint is receipt of blood transfusion within 7 days of surgery. Secondary outcomes include blood loss, postoperative complications, quality of life and 5-year disease-free and overall survival. Ethics and dissemination This trial has been approved by the research ethics boards at participating centres and Health Canada (parent control number 177992) and is currently enrolling participants. All participants will provide written informed consent. Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov. Trial registration number NCT02261415.

Original languageEnglish
Article numbere058850
JournalBMJ Open
Volume12
Issue number2
DOIs
Publication statusPublished - Feb 24 2022

Bibliographical note

Funding Information:
Funding This work was supported by the Canadian Institutes of Health Research (award/grant numbers: 378087, 365530, 311686 and 391834), Canadian Blood Services (award/grant number: CIHR201309RK-N-317906) and Physicians’ Services Incorporated Foundation (award/grant number: 14-21). Funders were not involved in the study design, collection, management, analysis, interpretation of data or writing.

Funding Information:
This trial is supported by the HPB CONCEPT Team. The HPB CONCEPT Team was created in 2011 to improve the care of patients with hepatopancreaticobiliary cancers through investigator-initiated research and to provide a forum for developing high-impact clinical trials. The HPB CONCEPT Team identified the investigation of TXA in patients undergoing liver resection as a priority research area with full endorsement.

Publisher Copyright:
©

ASJC Scopus Subject Areas

  • General Medicine

PubMed: MeSH publication types

  • Clinical Trial Protocol
  • Journal Article
  • Research Support, Non-U.S. Gov't

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