Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery

Aortic Disease Clinical Trial

— EACA  

Official title:

The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01965730
• Other study ID #: 816724
• Status: Terminated
• Phase: Early Phase 1
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Disease
• Aortic Diseases

Intervention

Drug:
• epsilon-aminocaproic acid (EACA)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of fibrinolysis as measured by thromboelastography	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.	Length of cardiac surgery