A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery
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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 |
- 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 |
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 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 October 17, 2012
