EUCTR2005-006202-26-NO进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel group, Dose Response Study of subcutaneous AVE5026 with an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery - TREK
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients planned to undergo elective TKR or a revision of a primary procedure performed = 6 months prior to study entry
- •- Men or women =18 years
- •- Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Related to study methodology:
- •- Any major orthopedic surgery in the 3 months prior to study start
- •- Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome
- •- Known sensitivity to iodine or contrast dyes
- •- Estimated creatinine clearance < 30 ml/min according to Cockroft and Gault formula
- •- Known progressive malignant disease
- •- Treatment with any investigational product or investigational device in the last 30 days prior to randomization
- •Relative to the reference calibrator:
- •- Uncontrolled arterial hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
- •- Ischemic stroke in the last 3 months or any history of hemorrhagic stroke
- •- Myocardial infarction (MI) in the last 3 months
- •- Active or recent (<3 months) significant bleeding, including gastrointestinal bleeding or peptic ulcer
- •- History of bleeding disorder (congenital, acquired or unexplained repeated bleeding episodes)
- •- Known structural damage or other pathologic process involving the central nervous system
- •- Recent (< 3 month) trauma, major surgery or ophthalmic surgery or parenchymal organ biopsy
- •- Treatment with other anti-thrombotic agents within 7 days prior to surgery
- •- Thrombocytopenia (platelet count = 100 x 109/l)
- •- Significant anemia (Hb < 10 g/dl)
- •- History of heparin-induced thrombocytopenia
- •- Any contra-indication to UFH or LMWH
- •Relative to AVE5026:
- •- Pregnant or nursing woman, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization
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