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

Last updated: November 9, 2009
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

3

Condition

Cardiac Surgery

Treatment

N/A

Clinical Study ID

NCT00588133
1216-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years old or greater having cardiac surgery.

Exclusion

Exclusion Criteria:

  • Age less than 18 years old.

  • Since tranexamic acid is not approved for pregnant patients, those extremely rarepatients that are pregnant and having cardiac surgery will be excluded from the study

Study Design

Total Participants: 20
Study Start date:
January 01, 2004
Estimated Completion Date:
August 31, 2008

Study 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.