PER-080-08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 Hip Fracture Surgery - SAVE-HIP2
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2009年1月9日最近更新:
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 80（—）
入选标准
- •Standard surgery for fracture of the upper third of the femur, including head and neck of the femur. Whether planned the first 36 hours after admission to the hospital and at 12 ± 1 hours after inclusion. Or, performed 8 ± 1 hours previously (from the time of closure of the incision), and whenever hemostasis has been established
- •Written informed consent signed
排除标准
- •Legal limitations of lower age (specific by country)
- •Estimated time of injury / fracture> 24 hours before hospital admission
- •Estimated time of surgery> 36 hours after admission to the hospital when pre-operative enoxaparin injection is administered according to the information to prescribe local enoxaparin
- •Any major orthopedic surgery in the 3 months before starting the study
- •Multiple injuries that affect more than one systemic organ
- •Clinical signs and symptoms of DVT or PD in the last 12 months or known post-phlebitic syndrome
- •Known sensitivity to iodine or contrast media, and any contraindication to the performance of venography
- •Any treatment with other antithrombotic agents in the 2 weeks before the random or planned distribution in the course of the study
- •Progressive malignant disease known
- •Subject with a low probability of complying with the protocol, for example, who has a non-cooperative attitude, is unable to return to follow-up visits, is unable to receive daily injection by the Healthcare Professional after hospital discharge and have little chance of completing the study
- •Treatment with any research product or research device in the last 30 days or 5 half lives (if relevant) before the random distribution
- •Any previous exposure to AVE5026 (eg, participation in any previous clinical study with AVE5026)
- •Major active bleeding
- •Thrombocytopenia associated with 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
- •Conditions with increased risk of bleeding, such as bacterial endocarditis, congenital or acquired bleeding disorders, active or angiodysplasic ulcerative gastrointestinal disease, hemorrhagic stroke or brief period after brain, spine or ophthalmic surgery
- •End-stage renal disease (estimated creatinine clearance <10 mL / min [see Appendix B]) or patient undergoing dialysis
- •Pregnant or lactating women
- •Women with reproductive potential who are not protected by a highly effective contraceptive method for birth control as defined in the Consent Informed Consent form throughout the study and / or are not willing or able to undergo pregnancy testing.
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