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

Heparin-Induced Thrombocytopenia Clinical Trial

Official title:

Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00603824
• Other study ID #: MHIRB # 2007-058
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: July 2010

Study information

• Verified date: June 2009
• Source: Methodist Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female at least 18 years of age;

• If female of childbearing potential, negative pregnancy test result;

• Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;

• Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).

Exclusion Criteria:

• Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);

• Pregnancy or lactating;

• Blood dyscrasia other than HIT;

• History of thrombocytopenia associated with fondaparinux;

• Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;

• Active bleeding of GI tract, GU tract, CNS or respiratory tract;

• Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;

• Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;

• Hypersensitivity or contraindication to warfarin or fondaparinux.

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia

Intervention

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
• argatroban or lepirudin
continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Methodist Healthcare	University of Tennessee

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet count recovery		5 days
Secondary	Recurrent thromboembolic complications		4 weeks