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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Cancer Tumour Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Care

No tranexamic acid

Group Type PLACEBO_COMPARATOR

No tranexamic acid

Intervention Type DRUG

Control

Dose 1

1 g bolus + 1 g infusion from induction over 8 hours

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Dose 2

1 g bolus + 10 mg/kg/hr from induction until end of surgery

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Interventions

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No tranexamic acid

Control

Intervention Type DRUG

Tranexamic Acid

Intervention Type DRUG

Other Intervention Names

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Cyklokapron

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No