CTRI/2010/091/000173已完成3 期
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
SanofiSynthelabo India Limited0 个研究点目标入组 4,400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 hepatobiliary 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/m2)
- • Chronic Heart Failure
- • Chronic Respiratory Failure
- • Inflammatory Bowel Disease
- • Cancer Surgery
- •Signed informed consent
排除标准
- •"Exclusion Criteria:
- •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 postphlebitic syndrome
- •6. Known sensitivity to iodine or contrast dyes, and any contraindications to the performance of venography
- •7. Any treatment or procedure with other antithrombotic agents 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 (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
- • Dextrans
- • Intermittent pneumatic compression of the legs (IPC)
- •8. Subject unlikely to comply with protocol, eg, 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 (eg, participation in any previous AVE5026 clinical trial)
- •Exclusion criteria related to enoxaparin
- •11. Active major bleeding
- •12. Thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of enoxaparin sodium
- •13. Known hypersensitivity to enoxaparin sodium (eg, 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 ophthalmological surgery.
- •Exclusion criteria related to AVE5026
- •16. End stage renal disease (estimated creatinine clearance <10 mL/min [see Appendix C]) or patient on dialysis
- •17. Pregnant or breastfeeding 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."
研究者
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