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Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery (EACA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01965730
Recruitment Status : Terminated (the study was suspended due to shortage of the study drug (amicar).)
First Posted : October 18, 2013
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events

Condition or disease Intervention/treatment Phase
Aortic Disease Drug: epsilon-aminocaproic acid (EACA) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: epsilon-aminocaproic acid (EACA)
75mg/kg loading dose with infusion 15mg/kg/hr
Drug: epsilon-aminocaproic acid (EACA)
Other Name: Amicar

Experimental: EACA
125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery.
Drug: epsilon-aminocaproic acid (EACA)
Other Name: Amicar




Primary Outcome Measures :
  1. degree of fibrinolysis as measured by thromboelastography [ Time Frame: Length of cardiac surgery ]
    The primary objective of the study will be to determine if a change in EACA dosing for cardiac surgery cases involving circulatory arrest actually leads to a quantifiable change in the degree of fibrinolysis as measured by TEG.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to sign informed consent
  • Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest

Exclusion Criteria:

  • Inability to sign informed consent
  • Baseline hypercoagulable condition as defined in medical record
  • Coronary disease with untreated lesions or recent coronary stent placement
  • Severe renal dysfunction (ESRD) as documented in medical record

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): NCT01965730


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Prakash A Patel, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01965730    
Other Study ID Numbers: 816724
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Keywords provided by University of Pennsylvania:
dilated ascending aorta
Additional relevant MeSH terms:
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Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants