NCT01352039

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 544 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Hip Fracture Surgery

Interventions

Type	Name	Description
BIOLOGICAL	Heparin Sodium - Eurofarma	Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
BIOLOGICAL	Heparin Sodium - APP Pharmaceuticals	Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-10-01
• Completion: 2012-10-01
• First posted: 2011-05-11
• Last updated: 2012-10-16

Locations

5 sites across 1 country: Brazil