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NCT Number: NCT01651182

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

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Key information

Conditions

Cancer Hemorrhage Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgery Tumour

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No tranexamic acid

Drug

Control

Tranexamic Acid

Drug

Other names: Cyklokapron

Primary outcomes

  1. Receipt of blood transfusion(s)

    Time frame: 7 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • University Health Network, Toronto
  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2012
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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