Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Birmingham, Alabama 35233


Purpose:

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.


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.


NCT ID:

NCT00539942


Primary Contact:

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


Backup Contact:

N/A


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: January 19, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.