Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
Information source: Loma Linda University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiopulmonary Bypass
Intervention: Tranexamic Acid (Drug); Aminocaproic Acid (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Loma Linda University Official(s) and/or principal investigator(s):
Jason Gatling, MD, Principal Investigator, Affiliation: Loma Linda University Medical Center
Overall contact:
Jason Gatling, MD, Phone: 909-558-4475, Email: jgatling@llu.edu
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
Clinical Details
Official title: Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The primary outcome of the Tranexamic Acid Study is the amount of blood loss per patient in the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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?
Locations and Contacts
Jason Gatling, MD, Phone: 909-558-4475, Email: jgatling@llu.edu
Loma Linda University Medical Center, Loma Linda, California 92354, United States; Recruiting
Jason Gatling, MD, Phone: 909-558-4475, Email: jgatling@llu.edu
Patricia Moore, CCRP, Phone: 909-558-8493, Email: pamoore@llu.edu
Jason Gatling, MD, Principal Investigator
Additional Information
Starting date: March 2010
Last updated: June 9, 2011
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