Fondaparinux in Patients With Acute HIT
Information source: Methodist Healthcare
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heparin-Induced Thrombocytopenia
Intervention: fondaparinux (Drug); argatroban or lepirudin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Methodist Healthcare Official(s) and/or principal investigator(s):
Bob L Lobo, Pharm.D., Principal Investigator, Affiliation: Methodist University Hospital
Sohail Minhas, MD, Principal Investigator, Affiliation: University of Tennessee
Overall contact:
Bob L Lobo, Pharm.D., Phone: 901-516-8170, Email: lobob@methodisthealth.org
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.
Clinical Details
Official title: Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Platelet count recovery
Secondary outcome: recurrent thromboembolic complications
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Cockroft 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
Locations and Contacts
Bob L Lobo, Pharm.D., Phone: 901-516-8170, Email: lobob@methodisthealth.org
Methodist Healthcare, Memphis, Tennessee 38104, United States; Recruiting
Chris Finch, Pharm.D., Sub-Investigator
Additional Information
Starting date: January 2008
Ending date: July 2011
Last updated: January 16, 2008
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