RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, Double-Blind, Randomized Study of BAY59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement - Record 2

Phase 1

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

• Registration Number: EUCTR2005-004691-20-GB
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-01
• Study Completion: 2007-06-26
• 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 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

1. Planned, staged bilateral total 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 labelling of enoxaparin).
4. Significant liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis)
5. Conditions prohibiting bilateral veno graphy (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 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. Other concomitant medications not allowed (see § 4.5.7 of the study protocol)
13. Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the
investigator. (see § 4.5.7 of the study protocol)

Study & Design

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