Heparin-Induced Thrombocytopenia
Conditions
Keywords
heparin-Induced thrombocytopenia, fondaparinux
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.
Interventions
DRUGfondaparinux
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
DRUGargatroban or lepirudin
continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range
Sponsors
University of Tennessee
Methodist Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet count recovery | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent thromboembolic complications | 4 weeks |
Outcome results
None listed