prophylactic use of sodium enoxaparin for venous thromboembolism in high-risk abdominal surgery

Conditions: Venous Thromboembolism

Summary: 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

Eligibility criteria:
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.

Keywords: venous thromboembolism