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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01609686
First received: May 29, 2012
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  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 and urine 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 patients undergoing cardiopulmonary bypass for high-risk cardiac surgery aims to study the pharmacokinetics of TXA in patients with renal dysfunction, compare blood concentration and urine concentration of TXA and its metabolites in patients with and without renal dysfunction and corelate TXA levels during the perioperative periods with other tests of clot formation.

Hypothesis: Standard dosing of TXA used in high-risk 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: Case Control
Time Perspective: Prospective
Official Title: Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing High-risk Cardiac Surgery With the Use of Cardiopulmonary Bypass

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

    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 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


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIgh risk cardiac surgical patients

Criteria

Inclusion Criteria:

  • High-risk cardiac surgical patients above 18 years of age with normal renal function.
  • High-risk 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
  • Patients undergoing elective cardiac surgery who are at low to normal risk of bleeding.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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: May 31, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Heart Diseases
Kidney Diseases
Cardiovascular Diseases
Urologic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013