A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery

Exclusion Criteria

• •Patients who meet any of the following criteria will not be eligible for the study:
• •Previous hip surgery;
• •Fracture secondary to the presence of metastasis;
• •Recent traumatic brain, thoracic, or abdominal injury (up to 30 days before study start);
• •Recent occurrence (up to 30 days before study start) of cerebrovascular accident;
• •Serum concentration of hemoglobin below 9 g/dL;
• •Prior occurrence (in the last 5 years) of confirmed or suspected thromboembolic event;
• •Occurrence of major bleeding in the last 6 months (any spontaneous gastrointestinal bleeding; central nervous system bleeding; massive epistaxis, or gum bleeding; gross hematuria, or vaginal bleeding);
• •Confirmed or suspected blood dyscrasia;
• •Diagnosis of neoplasm other than in situ in the last 24 months or any active neoplasm (neoplasms in situ do not prevent patient from participating);
• •Liver or kidney failure;
• •Clinically significant gastrointestinal cardiovascular, neurological disease, or laboratory abnormalities, which at the investigator's opinion, may interfere with individual's participation in the study or with assessment of individual's response to treatment;
• •Hypersensitivity to heparin;
• •Previous use (15 days before study start) of oral anticoagulants or expected use during the study (see Appendix B);
• •Recent participation (previous 12 months) in a clinical trial.