Venous Thromboembolism Clinical Trial
Official title:
A Non-Inferiority Study of Enoxaparin Cristalia in Relation With Enoxaparin Sanofi-Aventis for Prophylaxis Against Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery
Verified date | July 2017 |
Source | Cristália Produtos Químicos Farmacêuticos Ltda. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 243 |
Est. completion date | April 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men and women aged above 18 years undergoing abdominal surgery with general high risk for developing venous thromboembolism; - Who have provided their consent by signing the consent form. Exclusion Criteria: - Clinical evidence of Venous thromboembolism (VTE) in the selection; - treatment requirement with anticoagulant Low Molecular Weight Heparin, Unfracted Heparin, oral anticoagulant - suspicion or history of coagulumpathia - Heparin, enoxaparin allergy or hypersensitiviy known to heparin, enoxaparin, but not restrict to thrombocytopenia and/or induce thombose by heparin ou enoxaparin (thrombocytopenia induce by heparin [TIH], thrombocytopenia associate with heparin [TAH] or thrombotic thrombocytopenia syndrome induce by heparin [STTIH] - Active bleeding that can be increased by enoxaparin. - Previous history of known intracranial hemorrhage - Artery-venous malformation or a suspicion or known cerebral aneurism - Spinal, Epidural ou lumbar puncture analgesia in the last 24 hours previous of the first dose of the administration of the enoxaparin. - erosive diseases of the digestive tract especially gastroduodenal - Uncontrolled hypertension (systolic blood pressure [BP]> 180mmHg or diastolic BP> 100 mm Hg) at randomization or clinical hypertensive urgency; - bacterial endocarditis - heart valve prosthesis - characterized by severe renal insufficiency creatinine clearance <30 ml / min - Intra-arterial thrombolic therapy - Thrombolic therapy within 24 hours. - Low Molecular Weight Heparin or Unfraction Heparin treatment with prophylactic dose over 48 hours before surgery or oral anticoagulant within 5 days before surgery - disturbance of consciousness and coma - Less than 6 months of expectative time life - Chemical dependency - Patient with anesthetic risk ASA III or ASA IV - morbid obesity with Body Mass Index = 40 - Chronic use of corticosteroids - History of allergy to Unfraction Heparin, Low molecular weight heparin or pork products. - History of severe allergic episode, systemic anaphylaxis, or major urticarial disease Steven-Johnson - Participation in another clinical study within 12 months prior to inclusion - Potentially fertile woman without ß-HCG negative harvested until 48 hours before operation or not using acceptable contraception for participation in this study - Changes the security checks up to 48 h before randomization: - Hemoglobin <10 mg / dL; - ALT or AST = 2.5 times ULN; - Platelet count <100.000/mL; - INR = 1.5; - Any condition which in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Regional da Asa Norte | Brasília | DF |
Brazil | Fundação de Desenvolvimento da Unicamp - FUNCAMP | Campinas | São Paulo |
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 | Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul |
Brazil | Hospital das Clínicas de Riberião Preto | Ribeirão Preto | São Paulo |
Brazil | Hospital Estadual Mario Covas | Santo Andre | São Paulo |
Brazil | Centro Multidisciplinar de Estudos Clínicos | Sao Bernardo do Campo | São Paulo |
Brazil | Fundação Faculdade Regional de Medicina de São José do Rio Preto | São Jósé do Rio Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Cristália Produtos Químicos Farmacêuticos Ltda. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 10 Days | |
Secondary | Safety of sodium enoxaparine | comparision between Endocris (sodium enoxaparin - Cristalia Prod. Quim. Farm.) versus Clexane (sodium enoxaparine - Sanofi-Aventis) in High-Risk Abdominal Surgery. | 10 days | |
Secondary | 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 | 10 days |
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