PER-123-08已完成未知
A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2008年12月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 60（—）
入选标准
- •Patients undergoing major surgery in the peritoneal and / or retroperitoneal area and / or the minor pelvis (although not limited to the minor pelvis) for indications not related to the liver (including the hepato-biliary system), the uterus or the prostate
- •Signed Informed Consent.
- •Patients under 60 years of age should have one of the following additional risk factors: History of VTE, Obesity (BMI> 30 kg / m2), Chronic heart failure, Chronic respiratory failure, Inflammatory Bowel Disease, Oncological surgery
排除标准
- •Limitations by minimum legal age (country specific)
- •Life expectancy less than 3 months
- •Known venous pelvic obstruction
- •Any major general or orthopedic surgery in the 3 months prior to the start of the study
- •Clinical signs or symptoms of VTE or PET within the last 12 months or known post phlebitic syndrome (the baseline physical examination to be performed prior to surgery will include the systematic evaluation of the signs and symptoms of VTE and will be used to confirm the absence of signs and symptoms of VTE before randomization of the patient in the study)
- •Known sensitivity to iodine or contrast fluids, and some contraindication to performing venography
- •Any treatment with other anti-thrombotic agents prior to randomization (5 half-lives according to the respective prescribing information) or planned during the course of the study
- •Subjects with little probability of complying with the protocol, for example with a non-cooperative attitude, inability to attend follow-up visits, inability to receive daily application (preferably from a Health Professional) after discharge from hospitalization and improbability of completing the study.
- •Treatment with any research product or device under investigation in the last 30 days or 5 half-lives (if applicable) prior to randomization
- •Any previous exposure to AVE5026 (eg previous participation in any clinical trial with AVES026)
- •Major active bleeding
- •Thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of enoxaparin sodium
- •Known hypersensitivity to enoxaparin sodium (eg pruritus, urticaria, anaphylactoid reactions)
- •Known hypersensitivity to heparin or pork products
- •Pictures with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired coagulation disorders, gastrointestinal active ulcerative and angiodysplastic disease, hemorrhagic stroke or short time after brain, spine or ophthalmologic surgery
- •End-stage renal impairment (estimated creatinine clearance <10 mL / min [see Appendix C]) or dialysis patients
- •Pregnant or breastfeeding women
- •Women of childbearing age, not protected by highly effective contraceptive methods as defined for contraception in the Informed Consent Form during the study term and / or who do not wish or cannot undergo pregnancy tests
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