Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection

Phase 3

Completed

• Conditions: Cancer; Tumour; Surgery
• Interventions: Drug: No tranexamic acid; Drug: Tranexamic Acid

• Registration Number: NCT01651182
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss and blood transfusion requirements in the following patient populations: multisystem trauma, liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver resection are at risk of severe perioperative blood loss and may also benefit from perioperative TXA administration.

This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic properties of two well studied dosing regimens of TXA will provide guidance in determining the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling evidence of the effectiveness of TXA comes from the large multicentred, multi-national CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h from the start of surgery until 2 hours after reperfusion of the liver transplant.

Although TXA is not currently approved for use in patients undergoing major liver resection, Health Canada has allowed the use of tranexamic acid for use in this research study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Study Start: 2014-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	No tranexamic acid	No tranexamic acid
Dose 1	Tranexamic Acid	1 g bolus + 1 g infusion from induction over 8 hours
Dose 2	Tranexamic Acid	1 g bolus + 10 mg/kg/hr from induction until end of surgery

Primary Outcome Measures

Name	Time	Method
Receipt of blood transfusion(s)	7 days

Secondary Outcome Measures

Name	Time	Method
Fibrinolytic Markers	Baseline - Postoperative Day 0-7
Pharmacokinetic Study	Baseline - Postoperative Day 0-7
Post-operative incidence of symptomatic venous thromboembolic event	30 days
Other post-operative complications	30 days

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada