A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588133
First received: December 25, 2007
Last updated: November 9, 2009
Last verified: November 2009

December 25, 2007
November 9, 2009
January 2004
December 2007   (final data collection date for primary outcome measure)
Plasma tranexamic acid levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00588133 on ClinicalTrials.gov Archive Site
Not Provided
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A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery
A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery

Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have developed an alternative dosing schedule for tranexamic acid. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule.

Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. The current dosing regimen for tranexamic acid was empirically derived based upon pharmacokinetics in normal patients receiving the drug. We have developed an assay for tranexamic acid and found that the plasma concentration of tranexamic acid varies greatly between patients and also over time within each patient, especially in patients with renal insufficiency. We have developed an alternative dosing schedule for tranexamic acid that incorporates the effects of renal function on tranexamic acid concentrations. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule. The results of this study will be used in a larger subsequent study of what level of plasma tranexamic acid concentration is needed to prevent bleeding and transfusion of blood products in patients undergoing cardiac surgery.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiac Surgery
  • Drug: tranexamic acid

    Loading dose: 6.6 mg/kg Prime dose: 50 mg for 2.5 Liter circuit (assuming 1 L/kg Vd in prime fluids), 40 mg for 2 Liter circuit Rate of infusion: 6 mg/kg/hr

    Renal Insufficiency (normal loading dose and prime dose):

    Serum Creatinine = 1.6-3.3: reduce infusion to 4.5 mg/kg/hr Serum Creatinine = 3.3-6.6: reduce infusion to 3.0 mg/kg/hr Serum Creatinine = >6.6: reduce infusion to 1.5 mg/kg/hr

    Other Name: Cyclokapron
  • Drug: tranexamic acid
    10 mg/kg tranexamic acid given over 20 minutes followed by an infusion of 1 mg/kg/hr
    Other Name: Cyclokapron
  • Experimental: 1
    New drug dosing schedule
    Intervention: Drug: tranexamic acid
  • Active Comparator: 2
    Standard drug dosing schedule
    Intervention: Drug: tranexamic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years old or greater having cardiac surgery.

Exclusion Criteria:

  • Age less than 18 years old.
  • Since tranexamic acid is not approved for pregnant patients, those extremely rare patients that are pregnant and having cardiac surgery will be excluded from the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00588133
1216-00
No
Gregory A. Nuttall, M.D., Mayo Clinic College of Medicine
Mayo Clinic
Not Provided
Principal Investigator: Gregory A. Nuttall, M.D. Mayo Clinic College of Medicine
Mayo Clinic
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP