Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery

NCT ID: NCT01248104

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-02-28

Brief Summary

We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.

Detailed Description

Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.

Conditions

Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tranexamic Acid

The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The TXA group re- ceived a bolus of 10 mg / kg over 15 minutes fol- lowed by an infusion of 1 mg/kg/hr.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

Infusion during cardiac surgery

Aminocaproic Acid

The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The EACA group received a bolus of 100 mg / kg given over 15 minutes shortly after induction of anesthesia followed by an infusion of 10 mg/kg/hr.

Group Type: ACTIVE_COMPARATOR

Aminocaproic Acid

Intervention Type: DRUG

Infusion during cardiac surgery

Interventions

Tranexamic Acid

Infusion during cardiac surgery

Intervention Type: DRUG

Aminocaproic Acid

Infusion during cardiac surgery

Intervention Type: DRUG

Other Intervention Names

TXA; Amicar

Eligibility Criteria

Inclusion Criteria

1. Is the subject 18 years of age or older?

2. Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?

3. Is the subject more than 30 kg ( 66 lbs)?

4. Does subject understand English?

Exclusion Criteria

1. Does the subject have existing coagulation defects (INR > 1.5, platelets < 100 ?

2. Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?

3. Does the subject have severe liver disease (AST & ALT> 3x normal) ?

4. Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?

5. Is the subject having any procedure where CPB is not anticipated?

6. Is the patient weight greater than 150 kg?

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Jason Gatling, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Gatling, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

Other Identifiers

5100064

Identifier Type: -

Identifier Source: org_study_id