Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
This trial is active, not recruiting.
|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|
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
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
The primary outcome of the Tranexamic Acid Study is the amount of blood loss per patient in the study.
time frame: 48 hours
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?
|Official title||Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery|
|Principal investigator||Jason Gatling, MD|
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