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

Tracking Information
First Submitted Date  ICMJE September 19, 2013
First Posted Date  ICMJE November 13, 2013
Results First Submitted Date  ICMJE April 1, 2016
Results First Posted Date  ICMJE June 30, 2016
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
Di-Dimer Increase Before Cardiopulmonary Bypass [ Time Frame: 8 months ]
Significant increase of Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.
Change History Complete list of historical versions of study NCT01981863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Value of Thromboelastography as Monitor of Fibrinolysis [ Time Frame: 6 months ]
Thromboelastography may display if fibrinolysis is present
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
Value of Thromboelastography as Monitor of Fibrinolysis [ Time Frame: 8 months ]
Thromboelastography shows theoretically fibrinolysis if present, but the relationship with the level of increase of Di-dimers is unknown.
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2016)
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
Original Other Pre-specified Outcome Measures
 (submitted: November 5, 2013)
Fibrinolysis before cardiopulmonary bypass? [ Time Frame: 8 months ]
 
Descriptive Information
Brief Title  ICMJE Fibrinolysis Before Cardiopulmonary Bypass?
Official Title  ICMJE Fibrinolysis Before Cardiopulmonary Bypass?
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pathologic Fibrinolysis
Intervention  ICMJE
  • Drug: Epsilonaminocaproic acid
    One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.
    Other Name: Amicar
  • Drug: Placebo
    Placebo administered in same volume as in experimental arm.
Study Arms  ICMJE
  • Experimental: Epsilonaminocaproic acid
    One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
    Intervention: Drug: Epsilonaminocaproic acid
  • Placebo Comparator: Placebo, Antifibrinolytic activity
    Placebo: same IV volume as experimental arm
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01981863
Other Study ID Numbers  ICMJE Fibrinolysis
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pieter JA Van der Starre, MD, PhD Stanford University
PRS Account Stanford University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP