EUCTR2007-007942-36-GBActive, not recruitingPhase 1
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 Major Abdominal Surgery - SAVE-ABDO
sanofi-aventis recherche & développement0 sites4,400 target enrollmentStarted: October 18, 2010Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 4,400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing major surgery in the peritoneal and/or the retroperitoneal space and/or the pelvis minor (but not limited to the pelvis minor) for indications other than limited disease of the liver (including hepato-biliary system), the uterus or the prostate. Patients with an age of <60 years must have one of the following additional risk factors: - History of VTE - Obesity (BMI =30 kg/m 2 ) - Chronic Heart Failure - Chronic Respiratory Failure - Inflammatory Bowel Disease - Cancer Surgery • Signed informed consent Note: Major surgery is defined as open surgery, under general anesthesia and lasting more than 45 minutes.
- •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. Life expectancy less than 3 months 3. Known pelvic venous obstruction 4. Any major orthopedic or general surgery in the 3 months prior to study start 5. Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome 6. Known sensitivity to iodine or contrast dyes, and any contra-indications to the performance of venography 7. Any treatment with other anti-thrombotic agents within 2 weeks prior to randomization or planned during the course of the study treatment period such as: - Parenteral anticoagulants (unfractionated heparin [UFH, LMWH [eg enoxaparin, dalteparin, nadroparin...], fondaparinux, bivalirudin, hirudin) - Oral anticoagulants (eg vitamin K antagonists) - GPIIb/IIIa antagonists: abciximab, eptifibatide, tirofiban - Thrombolytic agents Notes: Chronic treatment with anti-platelet agents such as low-dose of aspirin (up to 325 mg/day) or clopidogrel or ticlopidine in patients with coronary artery disease is allowed. To maintain the patency of a central venous catheter, saline flushing solutions are highly recommended. However, if it is local practice, flushing solutions with small amounts of heparin (max. 500 I.U.) are allowed. 8. 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 Health Care Professional) after hospital discharge and unlikelihood of completing the study 9. Treatment with any investigational product or investigational device in the last 30 days or 5 half lives (whichever is longer) prior to randomization. 10. Any previous exposure to AVE5026 (e.g. participation in any previous AVE5026 clinical trial) Note: A patient may not be randomized in the study more than once Exclusion criteria related to enoxaparin: 11. Active major bleeding 12. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium 13. Known hypersensitivity to enoxaparin sodium (e.g. pruritus, urticaria, anaphylactoid reactions) 14. Known hypersensitivity to heparin or pork products 15. 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: 16. End stage renal disease (estimated creatinine clearance <10 mL/min) or patient on dialysis 17. Pregnant or breast-feeding women 18. Women of childbearing potential not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form for the duration of the study and/or who are unwilling or unable to be tested for pregnancy. Note: Pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product.
Investigators
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