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Fibrinolysis Before Cardiopulmonary Bypass?

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. Identifier: NCT01981863
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Information provided by (Responsible Party):
Stanford University

Brief Summary:
It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.

Condition or disease Intervention/treatment Phase
Pathologic Fibrinolysis Drug: Epsilonaminocaproic acid Drug: Placebo Phase 4

Detailed Description:
Double-blind, placebo controlled, prospective study in two groups of 20 patients. Control group (A) receives standard Epsilonaminocaproic acid treatment before cardiopulmonary bypass (10 gr loading dose, and 1 gr/hr infusion), and second group (B) receives placebo. Before start of Epsilonaminocaproic acid/placebo, D-Dimers and Thromboelastography are measured, repeated just before full heparinization. After heparinization group A receives placebo, and group B Epsilonaminocaproic acid.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fibrinolysis Before Cardiopulmonary Bypass?
Study Start Date : July 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Epsilonaminocaproic acid
One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Drug: Epsilonaminocaproic acid
One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.
Other Name: Amicar

Placebo Comparator: Placebo, Antifibrinolytic activity
Placebo: same IV volume as experimental arm
Drug: Placebo
Placebo administered in same volume as in experimental arm.

Primary Outcome Measures :
  1. Di-Dimer Increase Before Cardiopulmonary Bypass [ Time Frame: 6 months ]
    Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.

Secondary Outcome Measures :
  1. Value of Thromboelastography as Monitor of Fibrinolysis [ Time Frame: 6 months ]
    Thromboelastography may display if fibrinolysis is present

Other Outcome Measures:
  1. Length of Time Between Incision and Cardiopulmonary Bypass [ Time Frame: From incision to bypass, up to 3 hours ]
    Mean Length of Time from Incision to Cardiopulmonary Bypass

Information from the National Library of Medicine

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

Inclusion Criteria:

  • All adult patients, undergoing first time sternotomy for Coronary artery bypass grafting/Aortic valve replacement/aortic surgery

Exclusion Criteria:

  • Resternotomy, renal insufficiency, deep hypothermia, age < 18 yrs

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 identifier (NCT number): NCT01981863

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United States, California
Stanford Hospital & Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Pieter JA Van der Starre, MD, PhD Stanford University

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Responsible Party: Stanford University Identifier: NCT01981863    
Other Study ID Numbers: Fibrinolysis
First Posted: November 13, 2013    Key Record Dates
Results First Posted: June 30, 2016
Last Update Posted: June 30, 2016
Last Verified: April 2016
Keywords provided by Stanford University:
cardiac surgery
cardiopulmonary bypass
antifibrinolytic agents
Additional relevant MeSH terms:
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Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action