This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.
To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
7
Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.
All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
UAB, Women's and Infant Center, 1700 6th Avenue South
Birmingham, Alabama, United States
Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.
Time frame: 21 days
Incidence of Untoward Effects With Arixtra
Adverse events will be evaluated to determine untoward effects.
Time frame: 21 days
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