The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.
This study is a requirement of Anvisa to add a new indication for off-label drug
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
243
40 mg/mL
clexane 40 mg/ 0,4 mL
Hospital Regional da Asa Norte
Brasília, Federal District, Brazil
Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC
Canoas, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Evaluation of Sodium enoxaparin to demonstrate non-inferiority
Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal
Time frame: 10 Days
Safety of sodium enoxaparine
comparision between Endocris (sodium enoxaparin - Cristalia Prod. Quim. Farm.) versus Clexane (sodium enoxaparine - Sanofi-Aventis) in High-Risk Abdominal Surgery.
Time frame: 10 days
Compare the incidence of venous thromboembolism and pulmonar embolism
Compare the incidence of venous thromboembolism and pulmonar embolism between 2 groups after 30 days of surgery
Time frame: 10 days
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Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Fundação de Desenvolvimento da Unicamp - FUNCAMP
Campinas, São Paulo, Brazil
Hospital das Clínicas de Riberião Preto
Ribeirão Preto, São Paulo, Brazil
Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São Jósé Do Rio Preto, São Paulo, Brazil