Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to prospectively evaluate the response of recombinant antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to undergo cardiac surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: rEVO Biologics
• Treatments: Antithrombin III; Antithrombins; Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• Patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB)

• Heparin resistant according to this definition: initial activated clotting time (ACT) after an intravenous loading dose of heparin (300 u/kg) is less than 480 seconds

Exclusion criteria:

• current use of one or more of these medications:

• warfarin (within 3 days of surgery);

• streptokinase;

• tissue plasminogen activator;

• abciximab,

• eptifibatide,

• tirofiban or

• clopidogrel.

• known hypersensitivity to goat or goat milk proteins,

• patients with pre-existing coagulopathy defined as a history of bleeding or laboratory bleeding disorder (e.g., von Willebrand disease, platelet disorder) and

• patients receiving direct thrombin inhibitors