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

Phase 4

Withdrawn

• Conditions: Heparin-Induced Thrombocytopenia
• Interventions: Drug: argatroban or lepirudin; Drug: fondaparinux

• Registration Number: NCT00603824
• Lead Sponsor: Methodist Healthcare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-29
• Status Verified: 2009-06
• Primary Completion: 2009-07
• Study Completion: 2010-07
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	argatroban or lepirudin	Direct thrombin inhibitor
A	fondaparinux	Fondaparinux

Primary Outcome Measures

Name	Time	Method
Platelet count recovery	5 days

Secondary Outcome Measures

Name	Time	Method
Recurrent thromboembolic complications	4 weeks