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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01609686
First received: May 29, 2012
Last updated: February 1, 2017
Last verified: May 2016
  Purpose

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.


Condition
Cardiac Disease
Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing Cardiac Surgery With the Use of Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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



Biospecimen Retention:   Samples Without DNA
Plasma

Enrollment: 49
Study Start Date: January 2012
Study Completion Date: March 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiac surgical patients with chronic renal dysfunction
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609686

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M8X 1W4
Sponsors and Collaborators
University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01609686     History of Changes
Other Study ID Numbers: 11-0165-B 
Study First Received: May 29, 2012
Last Updated: February 1, 2017

Keywords provided by University Health Network, Toronto:
cardiac surgery
renal dysfunction
pharmacokinetics
tranexamic acid

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on February 20, 2017