Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Graham Brown Cancer Center; University of Louisville
• Collaborators: James Graham Brown Cancer Center; University of Louisville
• Treatments: Calcium heparin; Fondaparinux; Heparin; PENTA; Warfarin

Criteria

Inclusion Criteria:

• high risk for HIT based on "Four Ts score" of 6 or more

Exclusion Criteria:

• pulmonary emboli at the time of enrollment

• arterial thrombosis at the time of enrollment

• limb threatening phlegmasia cerulea dolens at the time of enrollment

• Calculated Creatinin Clearance less than 50 ml/hr

• platelet count less than 50

• Weight less than 50 kg

• pregnancy

• allergy to fondaparinux

• bacterial endocarditis

• history of neuraxial anesthesia and post-operative indwelling epidural catheter

• active major bleeding (hemodynamically significant or requiring transfusions)

• inability to give informed consent