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

Launched by CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA. · Mar 2, 2011

Keywords

ClinConnect Summary

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

Gender

ALL

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.