Overview

This trial is active, not recruiting.

Condition cardiopulmonary bypass
Treatments tranexamic acid, aminocaproic acid
Sponsor Loma Linda University
Start date March 2010
End date March 2013
Trial size 100 participants
Trial identifier NCT01248104, 5100064

Summary

We hypothesize that tranexamic acid administration will be associated with 25% improvement in the volume of blood loss and red blood cell (RBC) administration, with no increase or a decrease in perioperative complications

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
tranexamic acid
Infusion during cardiac surgery
(Active Comparator)
aminocaproic acid
Infusion during cardiac surgery

Primary Outcomes

Measure
The primary outcome of the Tranexamic Acid Study is the amount of blood loss per patient in the study.
time frame: 48 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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?

Additional Information

Official title Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
Principal investigator Jason Gatling, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Loma Linda University.