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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
544
Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Centro de Pesquisa Clínica da Santa Casa de Misericórida de Juíz de Fora
Juiz de Fora, Minas Gerais, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).
Time frame: 6 months
The Secundary endpoint will be proximal and distal DVT
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Irmandade Santa Casa de Misericórdia de Marília
Marília, São Paulo, Brazil