Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

Inclusion Criteria

Scheduled to undergo major, open abdominal-pelvic surgery for known or presumed gynecologic malignancy
Age 18 years or older at the time of signing the consent
Gynecologic Oncology Group (GOG) performance status of ≤ 2
Life expectancy of > 3 months
Patient's weight must be ≥ 50 kg

Adequate organ function within 28 days of study entry defined as:

Hemoglobin ≥ 9.0 g/dL
Platelet ≥ 100,000 x 109/L
Blood urea nitrogen (BUN) ≤ 30 mg/dL
Serum creatinine ≤ 1.5 mg/dL
Not pregnant as determined by a negative urine or serum pregnancy test within 14 days of study enrollment
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria

Current treatment with anticoagulants
Thromboembolism within the previous 6 months
Bleeding/blood disorders (e.g., thrombocytopenia), gastrointestinal bleeding (e.g., active ulcers), history of stroke within past 3 years, or severe and currently uncontrolled high blood pressure
Bacterial endocarditis
Known hypersensitivity to fondaparinux sodium