A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588133

Purpose

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	Intervention	Phase
Cardiac Surgery	Drug: tranexamic acid	Phase III

MedlinePlus related topics: Heart Surgery

Drug Information available for: Tranexamic acid Creatinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Plasma tranexamic acid levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	January 2004
Study Completion Date:	December 2004
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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

Arms

Assigned Interventions

1: Experimental

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

2: Active Comparator

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588133

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Gregory A. Nuttall, M.D.

Mayo Clinic College of Medicine

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic College of Medicine ( Gregory A. Nuttall, M.D. )
Study ID Numbers:	1216-00
Study First Received:	December 25, 2007
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00588133
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

antifibrinolytic, bleeding, heart

Study placed in the following topic categories:

Antiplasmin
Tranexamic Acid
Hemorrhage

Additional relevant MeSH terms:

Fibrin Modulating Agents
Antifibrinolytic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Hematologic Agents
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009