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.

Phase 3

Completed

• Conditions: Patients undergoing total hip replacement.; Cardiovascular - Other surgery; Musculoskeletal - Other surgery

• Registration Number: ACTRN12606000068561
• Lead Sponsor: Bayer Australia Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-20
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

Patients scheduled for elective total hip replacement.- Patients’ written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures.

Exclusion Criteria

Planned, staged total bilateral hip replacement.- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin.- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin.- Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media).- Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. - Drug or alcohol abuse.- Concomitant use of 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.- Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of:<br>- Any DVT (proximal and/or distal)[Assessed at day 36];The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of:<br>- Non fatal PE[Assessed at day 36];The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of:<br>- Death from all causes.[Assessed at day 36]

Secondary Outcome Measures

Name	Time	Method
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE-related death.[Secondary efficacy endpoints as assessed at day 36 by venography.];Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death (composite of any DVT and nonfatal PE and VTE-related death).[Secondary efficacy endpoints as assessed at day 36 by venography.];Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE related death (composite of proximal DVT and nonfatal PE and death from all causes ).[Secondary efficacy endpoints as assessed at day 36 by venography.];Incidence of symptomatic VTE (DVT, PE).[Secondary efficacy endpoints as assessed at day 36 by venography.];Incidence of DVT (total, proximal, distal).[Secondary efficacy endpoints as assessed at day 36 by venography.];Incidence of symptomatic VTE during follow-up.[Secondary efficacy endpoints as assessed at day 36 by venography.]