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

Phase 3

Terminated

Interventions: Device: Intermittent compression devices (ICD)
Drug: Arixtra (fondaparinux sodium)

Brief Summary: 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.

Detailed Description: To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Intermittent compression devices (ICD)	Intermittent compression devices (ICD)	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.
Arixtra (fondaparinux sodium)	Arixtra (fondaparinux sodium)	Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge).

Primary Outcome Measures

Name	Time	Method
Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra	21 days	Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

Secondary Outcome Measures