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

Stopped early · Phase 3

Conditions studied: Venous Thrombosis

In brief

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.

Key facts

Study ID: NCT00539942
Run by: University of Alabama at Birmingham
People needed: 7
Starts: 2007-04-01
Expected to finish: 2010-06-01
Last updated by the study team: 2017-03-27

Who can join

Age: 19 and older, up to 85. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

UAB, Women's and Infant Center, 1700 6th Avenue South — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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