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

Completed · Phase 2

Conditions studied: Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Thromboembolism, Vaginal Cancer, Vulvar Cancer

In brief

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.

Key facts

Study ID

NCT00381888

Run by

Masonic Cancer Center, University of Minnesota

People needed

44

Starts

2007-01-01

Expected to finish

2009-01-01

Last updated by the study team

2017-12-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 qualify 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
• Bacterial endocarditis
• Known hypersensitivity to fondaparinux sodium

Where it is running

• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States
• Crozer-Chester Medical Center — Upland, Pennsylvania, United States

Full record on ClinicalTrials.gov

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