Understanding "Heparin Resistance" in Cardiac Surgery

Completed · Phase 1

Conditions studied: Cardiopulmonary Bypass, Altered Heparin Response

In brief

This study will explore altered heparin responsiveness (AHR) in cardiac surgical patients undergoing cardiopulmonary bypass (CPB) requiring systemic anticoagulation with heparin. The investigators will evaluate the hypothesis that AHR may be directly related to, modulated or mediated by interactions between heparin, antithrombin (AT), the heparin-AT complex, and one or more acute phase proteins. The investigators are particularly interested in identifying patients with "true heparin resistance", that is, patients who demonstrate AHR even after antithrombin-replenishment in the presence of an adequate systemic dose of heparin.

Key facts

Study ID

NCT01598883

Run by

Massachusetts General Hospital

People needed

504

Starts

2012-06-01

Expected to finish

2014-12-01

Last updated by the study team

2016-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients scheduled for elective cardiac or aortic surgery requiring CPB for which heparin will be used for systemic anticoagulation
• Patients scheduled for urgent surgery who are hemodynamically stable and capable of giving voluntary consent
• Patients with platelet factor 4 antibody positivity (antiPF4+) for whom heparin anticoagulation will be used

You may not qualify if…

• Patients for whom heparin will not be used for anticoagulation
• Patients with known congenital AT-deficiency
• Patients with known goat milk allergy

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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