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

September 17, 2015 updated by: Sunnybrook Health Sciences Centre

Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patient undergoing anticipated open or laparoscopic major liver resection (> 2 hepatic segments), as assessed by the operating surgeon
  • Age ≥ 18 years.

Exclusion Criteria

  • Previously enrolled in this study
  • Platelet count less than 100,000/mm3
  • Severe anemia (hemoglobin levels less than 90 g/l)
  • Documented arterial or venous thrombosis at screening or in past three months
  • Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
  • Hepatectomy associated with planned vascular or biliary reconstruction
  • Known disseminated intravascular coagulation
  • Severe renal insufficiency (CrCl<30)
  • History of seizure disorder
  • Pregnant or lactating
  • Hypersensitivity to tranexamic acid or any of the ingredients
  • Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction)
  • Receipt of chemotherapy within 4 weeks of scheduled operation
  • Patients undergoing resection for living donor liver transplant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard Care
No tranexamic acid
Drug: No tranexamic acid
Control
Experimental: Dose 1
1 g bolus + 1 g infusion from induction over 8 hours
Drug: Tranexamic Acid
Other Names:
  • Cyklokapron
Experimental: Dose 2
1 g bolus + 10 mg/kg/hr from induction until end of surgery
Drug: Tranexamic Acid
Other Names:
  • Cyklokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Receipt of blood transfusion(s)
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

University Health Network, Toronto
University of Toronto

Investigators

  • Principal Investigator: Paul Karanicolas, MD PhD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXA Liver - PK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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