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

NCT00603824 | Withdrawn Phase 4

• 1 other identifier: MHIRB # 2007-058
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

heparin-Induced thrombocytopenia; fondaparinux

Outcome Measures

Primary Outcomes (1)

• Platelet count recovery

  5 days

Secondary Outcomes (1)

• Recurrent thromboembolic complications

  4 weeks

Study Arms (2)

A

EXPERIMENTAL

Fondaparinux

Drug: fondaparinux

B

ACTIVE COMPARATOR

Direct thrombin inhibitor

Drug: argatroban or lepirudin

Interventions

fondaparinux 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

Also known as: Arixtra

A

argatroban or lepirudin DRUG

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

Also known as: Refludan

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Methodist Healthcare: lead
• University of Tennessee: collaborator

MeSH Terms

Interventions

Fondaparinux; argatroban; lepirudin

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Bob L Lobo, Pharm.D.

  Methodist University Hospital

  PRINCIPAL INVESTIGATOR

• Sohail Minhas, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 29, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2010
• Last Updated: August 13, 2019

Record last verified: 2009-06