Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a requirement of Anvisa to add a new indication for off-label drug

Official Title
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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

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Sodium enoxaparin
* Drug: Sodium Enoxaparin clexane


Participation Criteria
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Eligibility Criteria
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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 β-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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium enoxaparin<br>Endocris - 40 mg/0,4mL | Drug: Sodium enoxaparin<br>* 40 mg/mL<br>* Other names: Endocris;|
| Experimental: sodium enoxaparin Clexane<br>Clexane - 40 mg/ 0,4mL | Drug: Sodium Enoxaparin clexane<br>* clexane 40 mg/ 0,4 mL<br>* Other names: clexane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Thromboembolism