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

Study Overview
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Brief Summary
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The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.

Detailed Description
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The primary objective of the study is to assess the efficacy of unfractionated heparin sodium of porcine origin (Eurofarma) in the prophylaxis of VTE relative to unfractionated heparin sodium of porcine origin from APP Pharmaceuticals. The primary endpoint will be the frequency of DVT determined by Doppler ultrasound (DUS).

Official Title
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A Phase III, Non-inferiority, Randomized, Double-blind Trial Comparing Eurofarma Unfractionated Sodium Heparin 5,000 IU to APP Pharmaceuticals Unfractionated Sodium Heparin 5,000 IU in the Thromboprophylaxis of Geriatric Patients Who Underwent Hip Fracture Surgery.

Conditions
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Hip Fracture Surgery

Intervention / Treatment
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* Biological: Heparin Sodium - Eurofarma
* Biological: Heparin Sodium - APP Pharmaceuticals


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin Sodium - Eurofarma<br> | Biological: Heparin Sodium - Eurofarma<br>* Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI<br>|
| Active Comparator: Heparin Sodium - APP Pharmaceuticals<br> | Biological: Heparin Sodium - APP Pharmaceuticals<br>* Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secundary endpoint will be proximal and distal DVT |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heparin Sodium, Thromboprophylaxis, Hip Fracture Surgery.