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

This study has been withdrawn prior to enrollment.
(PI relocated)
Sponsor:
Collaborator:
University of Tennessee
Information provided by:
Methodist Healthcare
ClinicalTrials.gov Identifier:
NCT00603824
First received: January 4, 2008
Last updated: June 17, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Heparin-Induced Thrombocytopenia
 Drug: fondaparinux
Drug: argatroban or lepirudin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by Methodist Healthcare:

Primary Outcome Measures:
  • Platelet count recovery [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrent thromboembolic complications [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Fondaparinux
 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
Other Name: Arixtra
Active Comparator: B
Direct thrombin inhibitor
 Drug: argatroban or lepirudin
continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range
Other Name: Refludan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603824

Sponsors and Collaborators
Methodist Healthcare
University of Tennessee
Investigators
Principal Investigator: Bob L Lobo, Pharm.D. Methodist University Hospital
Principal Investigator: Sohail Minhas, MD University of Tennessee
  More Information

No publications provided

Responsible Party: Bob Lobo, Program Director, Clinical Pharmacy, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00603824     History of Changes
Other Study ID Numbers: MHIRB # 2007-058
Study First Received: January 4, 2008
Last Updated: June 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Methodist Healthcare:
heparin-Induced thrombocytopenia
fondaparinux

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Argatroban
Fondaparinux
PENTA
Lepirudin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013