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

Phase 3

Completed

• Conditions: Cardiac Surgery
• Interventions: Drug: tranexamic acid

• Registration Number: NCT00588133
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2007-12
• Study First Submitted: 2007-12-25
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-08
• Study Completion: 2008-08
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tranexamic acid	New drug dosing schedule
2	tranexamic acid	Standard drug dosing schedule

Primary Outcome Measures

Name	Time	Method
Plasma tranexamic acid levels	24 hours