A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery (HEP-SC)

This is an interventional prevention trial for Hip Fracture Surgery focused on measuring Heparin Sodium, Thromboprophylaxis, Hip Fracture Surgery. Read More

Inclusion Criteria:

In order to be enrolled in this study, eligible patients must meet all criteria below:

• ICF signing;
• Aged 60 to 85 years old;
• Indication of hip orthopedic surgery due to fracture occurred within the last 5 days;
• Normal coagulation profile or with alterations up to 25% of normal values.

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.