REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized dtudy of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement - RECORD 1

Phase 1

• Conditions: Prevention of venous thromboembolism; MedDRA version: 8.1Level: LLTClassification code 10012108

• Registration Number: EUCTR2005-004351-35-SK
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-13
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

Male and famale pyrients aged 18 years or above
Patients scheduled for elective total hip replacement
Ptients written informed consent for participation after detailed written and oral previous information to any study specific procedures
Are the trial subjects under 18?
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

1. Planned, staged total bilateral hp replacement.
2. Activebleeding or high risk of bleeding contanraindicating treatment with low molecular wight heparin.
3. Contraidictions 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 chlid-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- alcohol abuse.
7. Concomitant use of HIV-protease inhibitors.
8. Therapy with another investigational product within 30 days prior start of study.
9. Planed 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 otehr concomitant medication not allowed se section 4.5.7 of the study protocol

Study & Design

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