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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651182
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : September 18, 2015
Sponsor:
Collaborators:
University of Toronto
University Health Network, Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cancer Tumour Surgery Drug: No tranexamic acid Drug: Tranexamic Acid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Cyklokapron
Experimental: Dose 2
1 g bolus + 10 mg/kg/hr from induction until end of surgery
 Drug: Tranexamic Acid
Other Name: Cyklokapron


Outcome Measures
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Primary Outcome Measures :
  1. Receipt of blood transfusion(s) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Fibrinolytic Markers [ Time Frame: Baseline - Postoperative Day 0-7 ]
  2. Pharmacokinetic Study [ Time Frame: Baseline - Postoperative Day 0-7 ]
  3. Post-operative incidence of symptomatic venous thromboembolic event [ Time Frame: 30 days ]
  4. Other post-operative complications [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651182


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University of Toronto
University Health Network, Toronto
Investigators
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Principal Investigator: Paul Karanicolas, MD PhD Sunnybrook Health Sciences Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01651182    
Other Study ID Numbers: TXA Liver - PK
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015
Keywords provided by Sunnybrook Health Sciences Centre:
Blood transfusion
Blood loss
Postoperative complications
Outcome
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants