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

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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

Tracking Information
First Submitted Date  ICMJE July 24, 2012
First Posted Date  ICMJE July 26, 2012
Last Update Posted Date September 18, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
Receipt of blood transfusion(s) [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
Receipt of blood transfusion(s) [ Time Frame: 7 days ]
Transfusion of any blood product (red blood cells, fresh frozen plasma, platelets, or albumin) will be guided by a standardized protocol. Red blood cells will be transfused for Hgb<70, or Hgb 70-90 based on medical judgment with an indication provided by the transfusing clinician (coronary ischemia, hemodynamic instability, ongoing blood loss, etc). Fresh frozen plasma will be transfused for INR > 1.5 with active bleeding. Platelets will be transfused only if the patient is bleeding with platelet count < 50 x 109/L and cryoprecipitate only if patient is bleeding with fibrinogen < 1.0 g/L.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
  • Fibrinolytic Markers [ Time Frame: Baseline - Postoperative Day 0-7 ]
  • Pharmacokinetic Study [ Time Frame: Baseline - Postoperative Day 0-7 ]
  • Post-operative incidence of symptomatic venous thromboembolic event [ Time Frame: 30 days ]
  • Other post-operative complications [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
  • Total blood loss as assessed by Gross' formula [ Time Frame: 7 days ]
  • Intraoperative blood loss assessed by adding net weight of sponges and fluid suction (minus irrigation) [ Time Frame: Duration of anaesthesia ]
  • Total volume of blood transfused [ Time Frame: 7 days ]
  • Post-operative incidence of symptomatic venous thromboembolic event [ Time Frame: 30 days ]
  • Other post-operative complications [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection
Official Title  ICMJE Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Tumour
  • Surgery
Intervention  ICMJE
  • Drug: No tranexamic acid
    Control
  • Drug: Tranexamic Acid
    Other Name: Cyklokapron
Study Arms  ICMJE
  • Placebo Comparator: Standard Care
    No tranexamic acid
    Intervention: Drug: No tranexamic acid
  • Experimental: Dose 1
    1 g bolus + 1 g infusion from induction over 8 hours
    Intervention: Drug: Tranexamic Acid
  • Experimental: Dose 2
    1 g bolus + 10 mg/kg/hr from induction until end of surgery
    Intervention: Drug: Tranexamic Acid
Publications * Karanicolas PJ, Lin Y, Tarshis J, Law CH, Coburn NG, Hallet J, Nascimento B, Pawliszyn J, McCluskey SA. Major liver resection, systemic fibrinolytic activity, and the impact of tranexamic acid. HPB (Oxford). 2016 Dec;18(12):991-999. doi: 10.1016/j.hpb.2016.09.005. Epub 2016 Oct 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01651182
Other Study ID Numbers  ICMJE TXA Liver - PK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE
  • University of Toronto
  • University Health Network, Toronto
Investigators  ICMJE
Principal Investigator: Paul Karanicolas, MD PhD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP