EUCTR2005-004620-40-ES进行中（未招募）1 期
Ensayo clínico controlado, doble ciego y aleatorizado de BAY 59-7939 en la prevención del tromboembolismo venoso en sujetos con cirugía electiva de sustitución total de rodilla. Estudio RECORD 3 RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; controlled, double-blind, randomized study of BAY 59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement - RECORD 3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Male and female patients aged 18 years or above
- •Subjects scheduled for elective total knee replacement
- •Subjects' written informed consent for participation after receiving detailed written and oral information on any study specific procedures
- •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
- •Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- •Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- •Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media)
- •Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. (Note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible both partners should use adequate barrier birth control).
- •Drug- or alcohol abuse
- •Concomitant HIV-protease inhibitors
- •Therapy with another investigational product within 30 days prior to start of study
- •Planned intermittent pneumatic compression during active treatment period
- •Concomitant participation in another trial or study
- •Other concomitant medications not allowed (see Section 4.5.7 of the protocol)
- •Subjects for whom therapy with anticoagulants cannot be stopped in the opinion of the investigator/physician (eg, phenprocoumon, warfarin-sodium, heparins, and Factor Xa inhibitors other than study medication)
研究者
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