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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose-ranging Study of Two Doses of Tranexamic Acid During Cardiac Surgery

NCT00809393

Cardiopulmonary Bypass Hemorrhage

COMPLETED PHASE4

Point-of-care Measurement of the Antifibrinolytic Activity of Tranexamic Acid in Cardiac Surgery

NCT06128330

Antifibrinolytic Agents

RECRUITING PHASE4

Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery

NCT07164300

Blood Coagulation Disorder Postoperative Blood Loss Adverse Drug Event +2 more

RECRUITING NA

The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients

NCT01895101

Blood Loss Tranexamic Acid Cardiac Surgery

COMPLETED PHASE4

Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery

NCT01519245

Coronary Artery Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

New drug dosing schedule

Group Type EXPERIMENTAL

tranexamic acid

Intervention Type DRUG

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

Standard drug dosing schedule

Group Type ACTIVE_COMPARATOR

tranexamic acid

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

tranexamic acid

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cyclokapron Cyclokapron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No