None listed
Conditions
Interventions
Group 1 Type of group
If the creatinine clearance is> 30ml / min AVE5026 20 mg in a volume of 0.4 ml will be administered, or if the creatinine clearance is 30ml / min Enoxaparin 40 mg in a volume of 0.4 ml will be administered, or if the creatinine clearance is
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Standard surgery for fracture of the upper third of the femur, including head and neck of the femur. Whether planned the first 36 hours after admission to the hospital and at 12 ± 1 hours after inclusion. Or, performed 8 ± 1 hours previously (from the time of closure of the incision), and whenever hemostasis has been established • Written informed consent signed
Exclusion criteria
Exclusion criteria: • Legal limitations of lower age (specific by country) • Estimated time of injury / fracture> 24 hours before hospital admission • Estimated time of surgery> 36 hours after admission to the hospital when pre-operative enoxaparin injection is administered according to the information to prescribe local enoxaparin • Any major orthopedic surgery in the 3 months before starting the study • Multiple injuries that affect more than one systemic organ • Clinical signs and symptoms of DVT or PD in the last 12 months or known post-phlebitic syndrome • Known sensitivity to iodine or contrast media, and any contraindication to the performance of venography • Any treatment with other antithrombotic agents in the 2 weeks before the random or planned distribution in the course of the study • Progressive malignant disease known • Subject with a low probability of complying with the protocol, for example, who has a non-cooperative attitude, is unable to return to follow-up visits, is unable to receive daily injection by the Healthcare Professional after hospital discharge and have little chance of completing the study • Treatment with any research product or research device in the last 30 days or 5 half lives (if relevant) before the random distribution • Any previous exposure to AVE5026 (eg, participation in any previous clinical study with AVE5026) • Major active bleeding • Thrombocytopenia associated with positive in vitro test for antiplatelet antibody in the presence of enoxaparin sodium • Known hypersensitivity to enoxaparin sodium (eg, pruritus, urticaria, anaphylactoid reactions) • Known hypersensitivity to heparin or pork products • Conditions with increased risk of bleeding, such as bacterial endocarditis, congenital or acquired bleeding disorders, active or angiodysplasic ulcerative gastrointestinal disease, hemorrhagic stroke or brief period after brain, spine or ophthalmic surgery • End-stage renal disease (estimated creatinine clearance <10 mL / min [see Appendix B]) or patient undergoing dialysis • Pregnant or lactating women • Women with reproductive potential who are not protected by a highly effective contraceptive method for birth control as defined in the Consent Informed Consent form throughout the study and / or are not willing or able to undergo pregnancy testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The results of the compulsory bilateral venography will be awarded by the CIAC, and only the results of the adjudication will be considered. • The clinical diagnosis of DVT of the lower extremities must be confirmed by compression ultrasound or venography • Clinical diagnosis of PE should be confirmed by ventilation / perfusion lung tracking, pulmonary angiogram, or lung scan by spiral computed tomography (CT) Measure:Compound of any VTE confirmed by the Central Independent Blind Adjudication Committee (CIAC) and deaths from any cause reported during the efficacy evaluation period Timepoints:The effectiveness evaluation period lasts from the day of the random assignment (Day 1 being the day of the random assignment at the end of the induction phase) to the day of a VTE confirmed by the CIAC, or until the day of mandatory bilateral venography (Day 19 - Day 24 after randomization), whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A symptomatic distal DVT will be defined as a distal DVT confirmed by appropriate diagnostic tests and associated with signs and / or symptoms consistent with VTE. A systematic tracking of signs and / or symptoms will be performed for VTE prior to any diagnostic test for VTE. Measure:Any proximal DVT, symptomatic distal DVT, nonfatal PE, and all causes of deaths reported during the efficacy evaluation period. Timepoints:The effectiveness evaluation period lasts from the day of the random assignment (Day 1 being the day of the random assignment at the end of the induction phase) to the day of a VTE confirmed by the CIAC, or until the day of mandatory bilateral venography (Day 19 - Day 24 after randomization), whichever comes first. ; Outcome name:The start of curative anticoagulant treatment will be recorded by the investigator Measure:The initiation of curative anticoagulant or thrombolytic therapy by the Investigator after the evaluation of local VTE during the efficacy evaluation period. Timepoints:The effectiveness evaluation period lasts from the day of the random assignment (Day 1 being the day of the random assignment at the end of the induction phase) to the day of a VTE confirmed by the CIAC, or until the day of mandatory bilateral venography (Day 19 - Day 24 after randomization), whichever comes first. ; Outcome name:Adverse events will be collected from the signing of the informed consent and then throughout the study to the post-treatment follow-up visit. Measure:Safety Timepoints:During the study | — |
Countries
Bulgaria, Czech Republic, Denmark, Finland, Greece, Italy, Portugal, Spain, Sweden
Outcome results
None listed