Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery
Stopped early · Phase 4
Conditions studied: Thrombophilia Due to Acquired Antithrombin III Deficiency
In brief
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.
Key facts
- Study ID
- NCT01547728
- Run by
- Mayo Clinic
- People needed
- 42
- Starts
- 2012-02-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2015-07-15
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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