NCT00603824

Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Methodist Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.

Conditions

• Heparin-Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	fondaparinux	fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if \>100 kg
DRUG	argatroban or lepirudin	continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-07-01
• Completion: 2010-07-01
• First posted: 2008-01-29
• Last updated: 2019-08-13