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

NCT00588133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-11-10

No results posted yet for this 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.

Conditions

  • Cardiac Surgery

Interventions

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

DRUG

tranexamic acid

10 mg/kg tranexamic acid given over 20 minutes followed by an infusion of 1 mg/kg/hr

Sponsors & Collaborators

Principal Investigators

  • Gregory A. Nuttall, M.D. · Mayo Clinic College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-12-31
Completion
2008-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00588133 on ClinicalTrials.gov