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

Early Phase 1TerminatedNCT01965730

University of Pennsylvania8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Aortic Disease

Interventions

epsilon-aminocaproic acid (EACA)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Length of cardiac surgery

Data from ClinicalTrials.gov

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