Safety Study of Fondaparinux Sodium to Prevent Venous Thromboembolic Events (APOLLO)

• Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
• Over 40 years of age

Inclusion Criteria:

• Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
• Over 40 years of age
• Subject who had signed the informed consent.

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 surgical closure.
• 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 of contrast medium,
• Patent with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo 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 give written 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 DVT prophylaxis 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 to concomitant 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 method during the whole duration of study participation ,
• Subject with body weight <50 kg,
• Subjects, who in the opinion of the investigator, required a pharmacological prophylaxis 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