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

Phase 1

• Conditions: Prevención del tromboembolismo venoso Prevention of venous thromboembolism; MedDRA version: 8.1 Level: LLT Classification code 10012108

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-16
• Study Completion: 2007-03-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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