EUCTR2007-007945-11-SEActive, not recruitingNot Applicable
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery - SAVE-HIP2
sanofi-aventis recherche & développement0 sites1,000 target enrollmentStarted: March 19, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients can be included only if they satisfy the following inclusion criteria:
- •1. Standard surgery for fracture of the upper third of the femur, including femoral head and neck.
- •2. Signed written informed consent.
- •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
- •Exclusion criteria related to study methodology:
- •1. Legal lower age limitations (country specific)
- •2. Estimated time of injury/fracture >24 hours before admission to hospital
- •3. Time from injury/fracture to surgery >60 hours
- •4. Any major orthopedic surgery in the 3 months prior to study start
- •5.multiple trauma affecting more than one organ system
- •6. Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome
- •7. Known sensitivity to iodine or contrast dyes and any contra-indications to the performance of venography
- •8. Any treatment or procedure within 2 weeks prior to randomization or planned during the course of the study treatment period, that could affect the incidence of VTE, such as:
- •- Parenteral anticoagulants (UFH, LMWH [i.e. enoxaparin, dalteparin, nadroparin,...],
- •fondaparinux, bivalirudin, hirudin)
- •- Oral anticoagulants (e.g. vitamin K antagonists...)
- •- GPIIb/IIIa antagonists: abciximab, eptifibatide, tirofiban
- •- Thrombolytic agents
- •- Dextrans
- •- Intermittent pneumatic compression of the legs (IPC)
- •Note: Chronic treatment with antiplatelet agents such as low-dose aspirin (up to 325 mg/day), clopidogrel or ticlopidine in patients with coronary artery disease is allowed
- •9. Known progressive malignant disease
- •10. Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to
- •return for follow-up visits, inability to receive daily injection (preferably by a nurse) after hospital discharge and unlikelihood of completing the study
- •11. Treatment with any investigational product or investigational device in the last 30 days or 5 half lives (whichever is longer, if relevant) prior to randomization
- •12. any previous exposure to AVE5026 (e.g participation in any previous AVE5026 clinical trial)
- •Exclusion criteria related to enoxaparin:
- •12. Active major bleeding
- •13. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium
- •14. Known hypersensitivity to enoxaparin sodium (e.g. pruritus, urticaria, anaphylactoid reactions)
- •15. Known hypersensitivity to heparin or pork products
- •16. Conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophtalmological surgery
- •Exclusion criteria related to AVE5026:
- •17. End stage renal disease (creatinine clearance <10 mL/min) or patient on dialysis
- •18. Pregnant or breast-feeding women
- •19. Women of childbearing potential not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and/or who are unwilling or unable to be tested for pregnancy.
- •Pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product.
Investigators
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