A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgery
Intervention: tranexamic acid (Drug); tranexamic acid (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Gregory A. Nuttall, M.D., Principal Investigator, Affiliation: Mayo Clinic College of Medicine
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.
Clinical Details
Official title: A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Plasma tranexamic acid levels
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Mayo Clinic Clinical Trials
Starting date: January 2004
Ending date: December 2004
Last updated: January 7, 2008
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