Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery
Early Phase 1
Terminated
- Conditions
- Aortic Disease
- Interventions
- Drug: epsilon-aminocaproic acid (EACA)
- Registration Number
- NCT01965730
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Ability to sign informed consent
- Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description EACA epsilon-aminocaproic acid (EACA) 125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery. epsilon-aminocaproic acid (EACA) epsilon-aminocaproic acid (EACA) 75mg/kg loading dose with infusion 15mg/kg/hr
- Primary Outcome Measures
Name Time Method degree of fibrinolysis as measured by thromboelastography 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States