Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing Cardiac Surgery With the Use of Cardiopulmonary Bypass

February 1, 2017 updated by: University Health Network, Toronto

Cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of patients. Tranexamic acid (TXA) is a routinely administered antifibrinolytic agent that reduces blood loss and blood transfusion requirement. However, standard dosing of TXA in patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may lead to higher blood concentration of TXA when compared to the patients with normal renal function. Solid phase microextraction (SPME) is a fast and simple method to measure TXA levels. This prospective study on cadiac surgical patients undergoing cardiopulmonary bypass aims to study the pharmacokinetics of TXA in patients with renal dysfunction. Two patient groups will be studied who will receive either TXA 50mg/kg bolus or BART regimen (30 mg/kg, 16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and bleeding risk.

Hypothesis: Standard dosing of TXA used in cardiac surgery result in higher blood concentration of TXA in patients with renal dysfunction when compared to patients with normal renal function.

Study Overview

Status

Status

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Completed

Conditions

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Observational

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49

Contacts and Locations

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Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M8X 1W4
        • Toronto General Hospital

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Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiac surgical patients with chronic renal dysfunction

Description

Inclusion Criteria:

  • Cardiac surgical patients above 18 years of age with renal dysfunction (stage 1, 2 ,3, 4 and 5 of the Kidney Disease Outcome Quality - Initiative classification of chronic kidney disease)

Exclusion Criteria:

  • All patients under 18 years of age or unable to give consent
  • Documented drug allergy to tranexamic acid
  • Deep hypothermic circulatory arrest
  • Pre-existing coagulopathy
  • Pregnancy
  • Advanced liver disease
  • Renal transplant recipients
  • Concomitant treatment with contraceptives, tretinonin

Study Plan

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How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

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Outcome Measure
Measure Description
Time Frame
Tranexamic acid blood concentration
Time Frame: Baseline, intraoperatively, postoperatively up to 72 hourss

Sampling schedule for blood TXA concentration Baseline (before administration of TXA) 5 minutes after TXA 10 minutes after TXA Post-sternotomy Before commencing CPB Every 30 mins on Cardiopulmonary bypass (CPB) Off CPB Prior to sternotomy closure Post-operative blood sampling schedule On admission to Intensive Care Unit (ICU)

1, 2, 4, 8, 12, 24, 48 and 72 hours post-op
Baseline, intraoperatively, postoperatively up to 72 hourss

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Sponsor

Sponsor

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University Health Network, Toronto

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Study Major Dates

Study Start

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January 1, 2012

Primary Completion (Actual)

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December 1, 2015

Study Completion (Actual)

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March 1, 2016

Study Registration Dates

First Submitted

First Submitted

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May 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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May 31, 2012

First Posted (Estimate)

First Posted

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June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

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February 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

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Other Study ID Numbers

Other Study ID Numbers

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  • 11-0165-B

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