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

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

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.