drugset / Trial / NCT00603824

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

NCT00603824

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-01
Primary completion
2009-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Argatroban Small molecule
Subject Fondaparinux Other / unclassified 5 mg Subcutaneous
Subject Fondaparinux Other / unclassified 7.5 mg Subcutaneous
Subject Fondaparinux Other / unclassified 10 mg Subcutaneous
Comparator Lepirudin Protein / enzyme biologic