Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial

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.

Inclusion Criteria:

• All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.
• Patients must be competent to self-administer injections, or must have caregivers or nurses who can perform injections
• Patients must have signed an approved informed consent

Exclusion Criteria:

• Patients with medical history which requires chronic anticoagulation (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)
• Patients with contraindications to anticoagulation (generalized bleeding disorders, peptic ulcer disease, hemorrhagic stroke, etc)
• Contraindications to placement of ICDs (history of lower extremity venous stasis ulcers)
• Patients receiving low molecular weight heparin or unfractionated heparin for prophylaxis post-operatively
• Patients who are unable to receive injections as an outpatient and/or unable to undergo a doppler ultrasound of the lower extremities
• Renal insufficiency (creatinine clearance < 30 mL/min)
• Patients who have a body weight < 50 kg
• Hypersensitivity to low molecular weight heparin
• Patients who are pregnant or have a positive pregnancy test.
• Patients receiving continuous (indwelling) epidural.