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

NCT ID: NCT00603824

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-07-31

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.

Conditions

Heparin-Induced Thrombocytopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Fondaparinux

Group Type: EXPERIMENTAL

fondaparinux

Intervention Type: DRUG

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

B

Direct thrombin inhibitor

Group Type: ACTIVE_COMPARATOR

argatroban or lepirudin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

argatroban or lepirudin

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

Intervention Type: DRUG

Other Intervention Names

Arixtra; Refludan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee

OTHER

Sponsor Role: collaborator

Methodist Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bob L Lobo, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Methodist University Hospital

Sohail Minhas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Other Identifiers

MHIRB # 2007-058

Identifier Type: -

Identifier Source: org_study_id