RECORD 4 Study: 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 4

Phase 1

• Conditions: Prevention of venous thromboembolism; MedDRA version: 8.1Level: LLTClassification code 10012108Term: Deep venous thrombosis prophylaxis

• Registration Number: EUCTR2006-002402-60-BG
• Lead Sponsor: Bayer Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

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

Inclusion Criteria

•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 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

Exclusion Criteria

•Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
•Contraindication listed in the labeling or conditions precluding subjects treatment with enoxaparin or requiring dose adjustment (eg, severe renal impairment)
•Conditions prohibiting bilateral venography (eg, 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 use of human immunodeficiency virus (HIV)-protease inhibitors
•Significant liver disease (eg, acute clinical hepatitis, chronic active hepatitis, cirrhosis)
•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)

Study & Design

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