None listed
Conditions
Interventions
Group 1 Type of group
(AVE5026 20 mg or AVE5026 10 mg) administered in syringes according to the estimated creatinine clearance at inclusion for 23 days
Group name:Group 2 Type of group
Placement syringes of the same appearance will be administered to the test product for 23 days.
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients can be included in the induction phase only if they meet the following selection criteria for inclusion (ENR): ENRl. Standard surgery for fracture of the upper third of the femur, including the head and neck of the femur with the closure of the incision made 8 ± 1 hours previously and once hemostasis has been established, ENR 2. Written informed consent signed Patients can be randomly assigned at the end of the induction phase only if they meet the following criteria for randomization: R1 Patients who completed the induction phase without the permanent discontinuation of AVE5026 prevention, R2. That still meet the selection criteria of the induction phase.
Exclusion criteria
Exclusion criteria: • Legal limitations due to minority (specific to the country) • Estimated time of injury / fracture before hospital admission> 24 hours. • Time from hospital admission to surgery> 36 hours. • Any major orthopedic surgery in the 3 months prior to the start of the study • Hemorrhagic cerebral vascular event or recent cerebral, vertebral or ophthalmic surgery (less than 3 months prior to inclusion). • Significant active or recent bleeding (<3 months) including gastrointestinal bleeding • Haemostasis not established prior to the first injection of AVE5026 in the induction phase • Clinical signs or symptoms of DVT or PE within 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 within 2 weeks prior to inclusion in the induction phase or planned during the course of the study • Progressive malignant disease known • Subjects with a low probability of complying with the protocol (eg, non-cooperative attitude, inability to return to follow-up visits, inability to receive the daily injection by a Health Care Professional) after hospital discharge and improbability of to complete the study • Treatment with any Product or Research device in the last 30 days or 5 half-lives (if relevant) prior to inclusion / random assignment • Any prior exposure to AVE5026 (eg participation in any previous AVE5026 clinical study) • Refusal or inability to give informed consent to participate in the study • History of heparin-induced thrombocytopenia • Known hypersensitivity to UFH OR LMWH • End-stage renal disease (estimated creatinine clearance <10 mL / min [see Appendix B]) or patient on dialysis • Pregnant or lactating women • Women with pregnancy potential not protected by an effective contraceptive method of birth control according to the definition of contraception in the Informed Consent Form for the duration of the study and / or those who are not willing or able to do a test of pregnancy • The occurrence of an exclusion criterion (1 to 20) • Withdrawal of consent • Permanent decontinuation of AVE5026 during the induction phase
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
Belarus, Brazil, Canada, Chile, China, Colombia, Egypt, India, Lithuania, Mexico, Peru, Russian Federation, South Africa, Turkey, Ukraine, United States
Outcome results
None listed