Understanding "Heparin Resistance" in Cardiac Surgery

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: rEVO Biologics
• Treatments: Antithrombins; Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients for whom heparin will not be used for anticoagulation

• Patients with known congenital AT-deficiency

• Patients with known goat milk allergy