Status:
COMPLETED
Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Cervical Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer. PURPOSE: This phase II trial is studying how well fondaparinux works i...
Detailed Description
OBJECTIVES: Primary * Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery. Seco...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00381888
Start Date
January 1 2007
End Date
January 1 2009
Last Update
December 28 2017
Active Locations (2)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Crozer-Chester Medical Center
Upland, Pennsylvania, United States, 19013