 Ecarin Clotting Time (ECT) Test
Pharmanetics has received an Humanitarian Device Exemption (HDE) for its Ecarin Clotting Time (ECT) test card from U.S. FDA www.fda.gov/cdrh/ode/h990012sum.html . The ECT HDE makes the test card available for monitoring the anticoagulation activity of r-hirudin (Refludan® <www.refludan.com>, Aventis Pharma) in patients with Heparin Induced Thrombocytopenia (HIT) undergoing Cardiopulmonary Bypass (CPB) procedures.
To obtain ECT test cards or for techincal information contact Jagruti Vyas by telephone at 919-582-2600 extension 2703 or by e-mail at .
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Information about how to obtain ECT test cards and the Humanitarian Device Exemption requirements can also be found in the ECT Instructions PDF.
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Heparin is the most commonly used anticoagulant in CPB procedures. The anticoagulant activity of unfractionated heparin is commonly monitored with the Activated Clotting Time (ACT). Patients with HIT however cannot receive heparin and r-hirudin is an effective alternative. The ACT is prolonged by r-hirudin and is therefore not suitable for monitoring this drug.
The Sawtooth Viper (Echis carinatus), pictured here, is the species from which the active component of the Ecarin Clotting Time test card is collected.
The ECT test card has been shown to be an effective monitor of the activity of r-hirudin in CPB patients.
The pages below contain information about the Pharmanetics ECT test card including:
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To view Adobe's Portable Document Format (PDF) , you will need Adobe Acrobat Reader; if you do not have it, follow the link below to download a copy.
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