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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Aminocaproic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is the subject 18 years of age or older? Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)? Is the subject more than 30 kg ( 66 lbs)? Does subject understand English? Exclusion Criteria: Does the subject have existing coagulation defects (INR > 1.5, platelets < 100 ? Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ? Does the subject have severe liver disease (AST & ALT> 3x normal) ? Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery? Is the subject having any procedure where CPB is not anticipated? Is the patient weight greater than 150 kg?

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic Acid<br>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. | Drug: Tranexamic Acid<br>* Infusion during cardiac surgery<br>* Other names: TXA;|
| Active Comparator: Aminocaproic Acid<br>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. | Drug: Aminocaproic Acid<br>* Infusion during cardiac surgery<br>* Other names: Amicar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Transfusion Amounts | The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Antifibrinolytic agents, Blood transfusion, epsilon aminocaproic acid, tranexamic acid