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
|Condition or disease||Intervention/treatment||Phase|
|Pathologic Fibrinolysis||Drug: Epsilonaminocaproic acid Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Fibrinolysis Before Cardiopulmonary Bypass?|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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
Placebo administered in same volume as in experimental arm.
- 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.
- Value of Thromboelastography as Monitor of Fibrinolysis [ Time Frame: 6 months ]Thromboelastography may display if fibrinolysis is present
- 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
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): NCT01981863
|United States, California|
|Stanford Hospital & Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||Pieter JA Van der Starre, MD, PhD||Stanford University|