Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer (NCT00381888) | Clinical Trial Compass
CompletedPhase 2
Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
United States44 participantsStarted 2007-01
Plain-language 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 in preventing blood clots in patients undergoing surgery for gynecologic cancer.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
What they're measuring
1
Number of Patients With Venous Thromboembolism at Week 4
Timeframe: Week 4 (Days 28-35)
Trial details
NCT IDNCT00381888
SponsorMasonic Cancer Center, University of Minnesota