PER-079-08已完成未知
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery - SAVE-HIP3
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:
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 80（—）
入选标准
- •Patients can be included in the induction phase only if they meet the following selection criteria for inclusion (ENR):
- •ENRl. Standard surgery for fracture of the upper third of the femur, including the head and neck of the femur with the closure of the incision made 8 ± 1 hours previously and once hemostasis has been established,
- •ENR 2. Written informed consent signed
- •Patients can be randomly assigned at the end of the induction phase only if they meet the following criteria for randomization:
- •R1 Patients who completed the induction phase without the permanent discontinuation of AVE5026 prevention,
- •R2. That still meet the selection criteria of the induction phase.
排除标准
- •Legal limitations due to minority (specific to the country)
- •Estimated time of injury / fracture before hospital admission> 24 hours.
- •Time from hospital admission to surgery> 36 hours.
- •Any major orthopedic surgery in the 3 months prior to the start of the study
- •Hemorrhagic cerebral vascular event or recent cerebral, vertebral or ophthalmic surgery (less than 3 months prior to inclusion).
- •Significant active or recent bleeding (<3 months) including gastrointestinal bleeding
- •Haemostasis not established prior to the first injection of AVE5026 in the induction phase
- •Clinical signs or symptoms of DVT or PE within 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 within 2 weeks prior to inclusion in the induction phase or planned during the course of the study
- •Progressive malignant disease known
- •Subjects with a low probability of complying with the protocol (eg, non-cooperative attitude, inability to return to follow-up visits, inability to receive the daily injection by a Health Care Professional) after hospital discharge and improbability of to complete the study
- •Treatment with any Product or Research device in the last 30 days or 5 half-lives (if relevant) prior to inclusion / random assignment
- •Any prior exposure to AVE5026 (eg participation in any previous AVE5026 clinical study)
- •Refusal or inability to give informed consent to participate in the study
- •History of heparin-induced thrombocytopenia
- •Known hypersensitivity to UFH OR LMWH
- •End-stage renal disease (estimated creatinine clearance <10 mL / min [see Appendix B]) or patient on dialysis
- •Pregnant or lactating women
- •Women with pregnancy potential not protected by an effective contraceptive method of birth control according to the definition of contraception in the Informed Consent Form for the duration of the study and / or those who are not willing or able to do a test of pregnancy
- •The occurrence of an exclusion criterion (1 to 20)
- •Withdrawal of consent
- •Permanent decontinuation of AVE5026 during the induction phase
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