Clinical Trial

Hemorrhage During Liver Resection

Study Description

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 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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

Additional Information

Official Study Title

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

Clinical Trial ID

NCT02261415

ParticipAid ID

Pe924a