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

Study Overview
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Brief Summary
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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.

Official Title
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Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia

Conditions
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Heparin-Induced Thrombocytopenia

Intervention / Treatment
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* Drug: fondaparinux
* Drug: argatroban or lepirudin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Fondaparinux | Drug: fondaparinux<br>* 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<br>* Other names: Arixtra;|
| Active Comparator: B<br>Direct thrombin inhibitor | Drug: argatroban or lepirudin<br>* continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range<br>* Other names: Refludan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count recovery |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent thromboembolic complications |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin-Induced thrombocytopenia, fondaparinux