Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Masonic Cancer Center, University of Minnesota
OBJECTIVES:
Primary
* Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery.
Secondary
* Evaluate the safety of this regimen in these patients (4 weeks).
* Determine the feasibility of this regimen in these patients (4 weeks).
OUTLINE: This is an open-label study.
Beginning after surgery, patients receive fondaparinux sodium subcutaneously once daily on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients undergo duplex ultrasonography of the lower extremities between day 28-35.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
You may not be if
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
