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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: GlaxoSmithKline
• Treatments: Fondaparinux; PENTA

Criteria

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.