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

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ClinicalTrials.gov Identifier: NCT01248104
Recruitment Status : Unknown
Verified April 2014 by Jason Gatling, MD, Loma Linda University.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2010
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Jason Gatling, MD, Loma Linda University

Brief 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

Condition or disease Intervention/treatment
Cardiopulmonary Bypass Drug: Tranexamic Acid Drug: Aminocaproic Acid

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
Study Start Date : March 2010
Primary Completion Date : March 2013
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Tranexamic Acid Drug: Tranexamic Acid
Infusion during cardiac surgery
Active Comparator: Aminocaproic Acid Drug: Aminocaproic Acid
Infusion during cardiac surgery



Primary Outcome Measures :
  1. The primary outcome of the Tranexamic Acid Study is the amount of blood loss per patient in the study. [ Time Frame: 48 hours ]
    1. We will be observing the amount of blood that is lost per patient in the accumulation of the chest tubes and bulb suction device outputs.
    2. Also the total amount of blood given (in ml) to the patients in the form of blood and blood product transfusions (pRBC, platelets, fresh frozen plasma and cryoprecipitate)will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248104


Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Jason Gatling, MD Loma Linda University Medical Center

Responsible Party: Jason Gatling, MD, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01248104     History of Changes
Other Study ID Numbers: 5100064
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by Jason Gatling, MD, Loma Linda University:
Cardiac Surgery
Antifibrinolytic agents
Blood transfusion
epsilon aminocaproic acid
tranexamic acid

Additional relevant MeSH terms:
Tranexamic Acid
Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants