Expired Study
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Birmingham, Alabama 35233


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 summary:

To assess the effectiveness of Arixtra in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.


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.



Primary Contact:

Principal Investigator
Warner K. Huh, M.D.
University of Alabama at Birmingham

Backup Contact:


Location Contact:

Birmingham, Alabama 35233
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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