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Completed

NCT Number: NCT01248104

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

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.

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Key information

Conditions

Cardiopulmonary Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Tranexamic Acid

Drug

Infusion during cardiac surgery

Other names: TXA

Aminocaproic acid

Drug

Infusion during cardiac surgery

Other names: Amicar

Primary outcomes

  1. Total Transfusion Amounts

    Time frame: 48 hours

    The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Nov 25, 2010
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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