Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery (EACA)

University of Pennsylvania

Status and phase: Terminated; Early Phase 1

Conditions: Aortic Disease

Treatments: Drug: epsilon-aminocaproic acid (EACA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01965730

816724

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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8 participants in 2 patient groups

epsilon-aminocaproic acid (EACA)

Active Comparator group

Description:

75mg/kg loading dose with infusion 15mg/kg/hr

Treatment:

Drug: epsilon-aminocaproic acid (EACA)

EACA

Experimental group

Description:

125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery.

Treatment:

Drug: epsilon-aminocaproic acid (EACA)