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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborators:
University of Toronto
University Health Network, Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01651182
First received: July 24, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cancer
Tumour
Surgery
Drug: No tranexamic acid
Drug: Tranexamic Acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Receipt of blood transfusion(s) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibrinolytic Markers [ Time Frame: Baseline - Postoperative Day 0-7 ] [ Designated as safety issue: No ]
  • Pharmacokinetic Study [ Time Frame: Baseline - Postoperative Day 0-7 ] [ Designated as safety issue: No ]
  • Post-operative incidence of symptomatic venous thromboembolic event [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Other post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cyklokapron
Experimental: Dose 2
1 g bolus + 10 mg/kg/hr from induction until end of surgery
Drug: Tranexamic Acid
Other Name: Cyklokapron

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651182

Contacts
Contact: Jenny Lam-MCulloch, MSc 416-480-6100 ext 85391 jenny.lam-mcculloch@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Paul Karanicolas, MD PhD    416-480-4774    paul.karanicolas@sunnybrook.ca   
Contact: Jenny Lam-McCulloch, MSc    416-480-6100 ext 85391    jenny.lam-mcculloch@sunnybrook.ca   
Principal Investigator: Paul Karanicolas, MD PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University of Toronto
University Health Network, Toronto
Investigators
Principal Investigator: Paul Karanicolas, MD PhD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01651182     History of Changes
Other Study ID Numbers: TXA Liver - PK
Study First Received: July 24, 2012
Last Updated: April 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Blood transfusion
Blood loss
Postoperative complications
Outcome

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014