Clinical trial NCT01308528 (phase 3, status: completed)
Conditions: venous thromboembolism
ICD codes: O88.22, O88.23, O88.211, O88.212, O88.213, O88.219
Drugs: sodium enoxaparin, sodium enoxaparin clexane
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
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.