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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00588133
Collaborator
(none)
20
Enrollment
2
Arms
55
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: tranexamic acid
  • Drug: tranexamic acid
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

New drug dosing schedule

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 Names:
  • Cyclokapron

    		•
    Active Comparator: 2

    Standard drug dosing schedule

    Drug: tranexamic acid
    10 mg/kg tranexamic acid given over 20 minutes followed by an infusion of 1 mg/kg/hr
    Other Names:
  • Cyclokapron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma tranexamic acid levels [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Gregory A. Nuttall, M.D., Mayo Clinic College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00588133
    Other Study ID Numbers:
    • 1216-00
    First Posted:
    Jan 8, 2008
    Last Update Posted:
    Nov 10, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    antifibrinolytic, bleeding, heart
    Additional relevant MeSH terms:
    Tranexamic Acid

    Study Results

    No Results Posted as of Nov 10, 2009