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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588133
First received: December 25, 2007
Last updated: November 9, 2009
Last verified: November 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery

Resource links provided by NLM:


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: August 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cyclokapron

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Gregory A. Nuttall, M.D., Mayo Clinic College of Medicine
ClinicalTrials.gov Identifier: NCT00588133     History of Changes
Other Study ID Numbers: 1216-00
Study First Received: December 25, 2007
Last Updated: November 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
antifibrinolytic, bleeding, heart

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014