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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651182
• Other study ID #: TXA Liver - PK
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2012
• Last updated: September 17, 2015
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Surgery
• Tumour

Intervention

Drug:
• No tranexamic acid
Control
• Tranexamic Acid

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	University Health Network, Toronto, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of blood transfusion(s)		7 days	No
Secondary	Fibrinolytic Markers		Baseline - Postoperative Day 0-7	No
Secondary	Pharmacokinetic Study		Baseline - Postoperative Day 0-7	No
Secondary	Post-operative incidence of symptomatic venous thromboembolic event		30 days	No
Secondary	Other post-operative complications		30 days	No