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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.

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).

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.

Arixtra (fondaparinux sodium)

Intermittent compression devices (ICD)

Warner K. Huh, M.D.

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 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

Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

Adverse events will be evaluated to determine untoward effects.

GlaxoSmithKline

University of Alabama at Birmingham

Principal Investigator

Patients will receive standard intermittent compression devices (ICD's) during 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.

Intermittent Compression Devices

Patients randomized to treatment arm will initiate ARIXTRA 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 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)

Arixtra (Fondaparinux Sodium)

Fondaparinux (Arixtra)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This trial was terminated early due to poor enrollment and recruitment and the very small number of subjects analyzed. As such, the data is uninterpretable.

Warner K. Huh, MD

Patients will receive intermittent compression devices (ICD's) during the 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.

Patients randomized to the Arixtra arm will initiate 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 and after hospital discharge)

Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.

Spots Global Cancer Trial Database for arixtra (fondaparinux sodium)