NCT00539942

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 19 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Arixtra (fondaparinux sodium)	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.
DEVICE	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.

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-10-05
• Last updated: 2017-03-27
• Results posted: 2012-03-09

Locations

1 site across 1 country: United States