NCT01308528已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 9
- 主要终点
- Evaluation of Sodium enoxaparin to demonstrate non-inferiority
研究概览
简要总结
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.
详细描述
This study is a requirement of Anvisa to add a new indication for off-label drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sodium enoxaparin
Experimental
Endocris - 40 mg/0,4mL
干预措施: Sodium enoxaparin (Drug)
sodium enoxaparin Clexane
Experimental
Clexane - 40 mg/ 0,4mL
干预措施: Sodium Enoxaparin clexane (Drug)
结局指标
主要结局
Evaluation of Sodium enoxaparin to demonstrate non-inferiority
时间窗: 10 Days
Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal
次要结局
- Safety of sodium enoxaparine(10 days)
- Compare the incidence of venous thromboembolism and pulmonar embolism(10 days)
研究者
研究点 (9)
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