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

Bayer HealthCare AG0 个研究点目标入组 4,200 人开始时间: 2005年11月22日最近更新: 2012年3月19日

研究概览

暂无简介。

•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 information prior 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

•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 or requiring dose adjustment(e.g.severe renal impairment, please refer to the local label of enoxaparin of your country).
•4. Signinficant liver disease(e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis)
•5. Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media).
•6. 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).
•7. Drug- or alcohol abuse.
•8. Concomitant use of HIV-protease inhibitors.
•9. Therapy with another investigational product within 30 days prior start of study.
•10. Planned intermittent pneumatic compression during active treatment period.
•11. Concomitant participation in another trial or study.
•12. Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator (see section 4.5.7 of the study protocol)
•13. For other concomitant medication not allowed see section 4.5.7 of the study protocol

发起方