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

Hip Fracture Surgery Clinical Trial

Official title: 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.

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture Surgery
• Hip Fractures

• NCT number: NCT01352039
• Study type: Interventional
• Source: Eurofarma Laboratorios S.A.
• Status: Terminated
• Phase: Phase 3
• Start date: October 2011
• Completion date: October 2012