EUCTR2005-004351-35-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 pacientes con cirugía electiva de sustitución total de cadera. Estudio RECORD 1 RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement - RECORD 1
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.
- •Patients scheduled for elective total hip replacement.
- •Patients’ written informed consent for participation after receiving detailed written and oral previous information to 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
- •1. Planned, staged total bilateral hip replacement.
- •2. Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin.
- •3. Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin.
- •4. Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media).
- •5. 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).
- •6. Drug- or alcohol abuse.
- •7. Concomitant use of HIV-protease inhibitors.
- •8. Therapy with another investigational product within 30 days prior start of study.
- •9. Planned intermittent pneumatic compression during active treatment period.
- •10. Concomitant participation in another trial or study.
- •11. Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator (see section 4.5.7 of the study protocol)
- •12. For other concomitant medication not allowed see section 4.5.7 of the study protocol
研究者
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