Phase
Condition
Thromboembolism
Treatment
N/AClinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor)lasting longer than 45 minutes (duration from anesthesia induction to surgicalclosure)
Over 40 years of age
Subject who had signed the informed consent.
Exclusion
Exclusion Criteria:
Active, clinically significant bleeding
Documented congenital or acquired bleeding tendency/disorders
Active ulcerative gastrointestinal disease unless the reason for the present surgery.
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation)brain, spinal, or ophthalmologic surgery.
Indwelling intrathecal or epidural catheters for more than 6 hours after surgicalclosure.
Subjects who had a traumatic puncture or unusual difficulty in applying the catheter
Known cerebral metastasis,
Subjects in whom hemostasis had not been established 6 hours after surgical closure,
Current thrombocytopenia,
Bacterial endocarditis
Creatinine level above 2.0 mg/dL (180 μmol/L) in a well-hydrated subject,
Documented hypersensitivity to contrast media,
Use of any contraindicated drug that could not be combined with the injection ofcontrast medium,
Patent with evidence of leg ischemia caused by peripheral vascular disease, unable toundergo IPC and unable to wear Elastic Stockings. Exclusion criteria related to trial methodology:
Mental disorders that could interfere with study participation and/or failure to givewritten informed consent to take part in the study,
Subject's life expectancy < 6 months,
Clinical sign of DVT and/or history of recent DVT,
Participation in any other therapeutic drug study or a device study evaluating DVTprophylaxis within 90 days preceding inclusion,
Previous participation in a study of fondaparinux sodium,
Known hypersensitivity to fondaparinux and its excipients,
Current addictive disorders that could interfere with study participation,
Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin,fibrinolytic agents or drugs blocking glycoprotein platelet receptors (GPIIb-IIIa)during the screening period, i.e., from admission to surgery,
Subjects for whom anticoagulant therapy was contraindicated or who had, due toconcomitant disease, an indication for oral anticoagulant or heparins (including LMWH)and who could not discontinue those treatments,
Women of child-bearing potential: women not using an appropriate contraceptive methodduring the whole duration of study participation ,
Subject with body weight <50 kg,
Subjects, who in the opinion of the investigator, required a pharmacologicalprophylaxis in addition to intermittent pneumatic compression,
Known pregnancy and / or women who intended to breastfeed,
Subjects undergoing vascular surgery such as aorto-femoral bypass graft
Study Design
Study Description
Connect with a study center
Princeton Baptist Medical Center
Birmingham, Alabama 35211-1399
United StatesSite Not Available
Scottsdale Urologic and Reproductive Specialists
Scottsdale, Arizona 85258
United StatesSite Not Available
Saguaro Surgical
Tucson, Arizona 85712
United StatesSite Not Available
Saddleback Medical Research Services
San Diego, California 92122
United StatesSite Not Available
Santa Barbara Cottage Hospital
Santa Barbara, California 93102
United StatesSite Not Available
Denver Health Medical Center
Denver, Colorado 80204
United StatesSite Not Available
PAB Clinical Research
Brandon, Florida 33511
United StatesSite Not Available
Baptist Regional Cancer Institute
Jacksonville, Florida 32207
United StatesSite Not Available
Surgical Associates of Central Florida, P.A.
Orlando, Florida 32804
United StatesSite Not Available
Sacred Heart Hospital
Pensacola, Florida 32503
United StatesSite Not Available
Sheridan Clinical Research Group
Sunrise, Florida 33323
United StatesSite Not Available
MCCA
Tampa, Florida 33612
United StatesSite Not Available
Rehabilitation Institute of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
UIC College of Medicine @ Peoria - Dept. of Surgery
Peoria, Illinois 61603
United StatesSite Not Available
Consultants in Pulmonary Medicine
Olathe, Kansas 66061
United StatesSite Not Available
Susan Galandiuk
Louisville, Kentucky 40202
United StatesSite Not Available
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky 42431
United StatesSite Not Available
Baystate Medical Center
Springfield, Massachusetts 01199
United StatesSite Not Available
VA Medical Center Hem/ONC Dept
Minneapolis, Minnesota 55417
United StatesSite Not Available
University of Mississippi Medical Center - Division of Urology
Jackson, Mississippi 39216-4505
United StatesSite Not Available
Truman Medical Center West - Dept of Surgery
Kansas City, Missouri 64108
United StatesSite Not Available
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
United StatesSite Not Available
Leonard Galler
Somers Point, New Jersey 08244
United StatesSite Not Available
Albany Medical Center
Albany, New York 12208
United StatesSite Not Available
State University of New York
Buffalo, New York 14203-1154
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
VA Medical Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Lehigh Valley Hospital
Allentown, Pennsylvania 18103
United StatesSite Not Available
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
St. Joseph's Hospital - Dept. of Surgery
Houston, Texas 77002
United StatesSite Not Available
McGuire VAMC
Richmond, Virginia 23249
United StatesSite Not Available
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