Study of Arixtra to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra: A Randomized Controlled Trial|
- Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra [ Time Frame: 21 days ] [ Designated as safety issue: No ]Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.
- Incidence of Untoward Effects With Arixtra [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]Adverse events will be evaluated to determine untoward effects.
|Study Start Date:||April 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
No Intervention: 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.
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 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge).
Drug: Fondaparinux sodium
Treatment will consist of daily injections of pharmacy prepared syringes of fondaparinux sodium 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22.
Other Name: Arixtra
To assess the effectiveness of Arixtra in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.
|United States, Alabama|
|UAB, Women's and Infant Center, 1700 6th Avenue South|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Warner K. Huh, M.D.||University of Alabama at Birmingham|