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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jason Gatling, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01248104
First received: November 15, 2010
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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 Intervention
Cardiopulmonary Bypass
Drug: Tranexamic Acid
Drug: Aminocaproic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • The primary outcome of the Tranexamic Acid Study is the amount of blood loss per patient in the study. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: February 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tranexamic Acid Drug: Tranexamic Acid
Infusion during cardiac surgery
Active Comparator: Aminocaproic Acid Drug: Aminocaproic Acid
Infusion during cardiac surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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?
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jason Gatling, MD, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01248104     History of Changes
Other Study ID Numbers: 5100064
Study First Received: November 15, 2010
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Aminocaproic Acid
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014