REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a controlled, double-blind, randomized study of BAY 59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement - RECORD 3

• Conditions: Prevention of VTE in patient undergoing elective total knee replacement; MedDRA version: 9.1Level: HLGTClassification code 10014523Term: Embolism and thrombosis

• Registration Number: EUCTR2005-004620-40-IT
• Lead Sponsor: BAYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

Male and female subjects 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

Exclusion Criteria

Active bleeding or high risk of bleeding contraindicating treatment with LMWH; Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin; Conditions prohibiting bilateral venography (amputation of 1 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 use of human immunodeficiency virus (HIV)-protease inhibitors; Therapy with another investigational product within 30 days prior start of study; Planned intermittent pneumatic compression during active treatment period; Concomitant participation in another trial or study; Other concomitant medications not allowed; 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified