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

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248104
• Other study ID #: 5100064
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: February 2015

Study information

• Verified date: September 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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?

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

Drug:
• Tranexamic Acid
Infusion during cardiac surgery
• Aminocaproic Acid
Infusion during cardiac surgery

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Transfusion Amounts	The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.	48 hours