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

Not Applicable

Completed

• Conditions: Cardiopulmonary Bypass
• Interventions: Drug: Tranexamic Acid; Drug: Aminocaproic Acid

• Registration Number: NCT01248104
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2013-03
• Study Completion: 2015-02
• Results First Submitted: 2016-10-11
• Results First Submitted QC: 2020-08-12
• Results First Posted: 2020-08-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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?

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	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.
Aminocaproic Acid	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.

Primary Outcome Measures

Name	Time	Method
Total Transfusion Amounts	48 hours	The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States