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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

Page last updated: December 08, 2011

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