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

NCT00603824 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-08-13

No results posted yet for this study

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

Interventions

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

DRUG

argatroban or lepirudin

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

Sponsors & Collaborators

  • University of Tennessee

    collaborator OTHER

  • Methodist Healthcare

    lead OTHER

Principal Investigators

  • Bob L Lobo, Pharm.D. · Methodist University Hospital

  • Sohail Minhas, MD · University of Tennessee

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-07-31
Completion
2010-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603824 on ClinicalTrials.gov