EUCTR2014-001954-40-PL进行中（未招募）不适用
A randomized, multicenter, parallel, open-label study comparing the safety of the test investigational medicinal product (IMP) Enoxaparin Sodium 40 with the reference IMP Clexane for the prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk knee surgery.
SciencePharma spólka z ograniczona odpowiedzialnoscia sp. k.0 个研究点开始时间: 2014年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Caucasian male or female patients scheduled to undergo elective, unilateral major knee surgery, including patients requiring a revision of at least one component of a previously implanted total-knee prosthesis, eligible for 14 days prophylaxis against VTE with enoxaparin;
- •2. 18 years of age or older;
- •3. Body weight > 45 kg in females and > 57 kg in males;
- •4. Patients capable of understanding and following the study procedures, who will give their Informed Consent in a written form before any study qualification procedures begin.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1. Contraindications to surgery or any medical procedure required by the type of surgery (e.g. type of anaesthesia, urinary catherization if required etc.);
- •2. Contraindications to enoxaparin treatment in accordance with Clexane SmPC:
- •acute bacterial endocarditis;
- •active major bleeding;
- •conditions with a high risk of uncontrolled haemorrhage (e.g. recent haemorrhagic stroke);
- •active gastric or duodenal ulceration;
- •hypersensitivity to either enoxaparin sodium, heparin or its derivatives including other low molecular weight heparins;
- •3. History of immune-mediated heparin-induced thrombocytopenia (HIT type II) and/or thromboembolism (HITT);
- •4. Known any bleeding diathesis;
- •5. Known inherited thrombophilic disorder such as the factor V Leiden or prothrombin gene mutations or deficiencies of antithrombin, protein C, or protein S;
- •6. Abnormal results of blood coagulation tests (activated partial thromboplastin time (aPTT), prothrombin time (PT), International Normalized Ratio (INR));
- •7. Anaemia (HGB < 12 g/dL in females and < 13.0 g/dL in males);
- •8. Thrombocytopenia (PLT < 150 000/mm3), also if in history;
- •9. Thrombocytosis (PLT > 400 000/mm3), also if in history;
- •10. History of intracerebral, intraocular, gastrointestinal or urogenital bleeding, or active gastric or duodenal ulceration, within 6 months prior to randomization;
- •11. History of major surgery (invasive medical procedures involving tissues incision, requiring general or intrathecal anesthesia, access into the cavities of the body, associated with significant risk of major bleeding or in which the life of a patient is at stake, e.g. cardiac surgery, neurosurgery, ophthalmic surgery, abdominal surgery) within 3 months prior to randomization;
- •12. History of major trauma (defined as tissue, organ or large area of the body injury due to the action of mechanical, thermal, chemical or electrical factor etc.) within 3 months prior to randomization;
- •13. History of any thrombolytic or fibrynolysis inhibitor or anticoagulant use (except for heparins) within 4 weeks prior to randomization;
- •14. History of any heparin use within 100 days prior to randomization;
- •15. History of any antiplatelet use within 5 days prior to randomization;
- •16. Uncontrolled hypertension defined as systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening or at any time within 3 months prior to randomization;
- •17. Hyperkalemia;
- •18. History of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, cerebrovascular accident (CVA), or transient ischemic attack (TIA), within 6 months prior to randomization;
- •19. Severe cardiac failure (NYHA III-IV);
- •20. Unstable angina pectoris;
- •21. Known liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels more than three times the upper limit of the normal range;
- •22. Known renal disease (calculated creatinine clearance < 30 mL/min) or patients on dialysis;
- •23. Any suspected urinary tract infection;
- •24. Active oral cavity infections;
- •25. History of malignant neoplastic disease that has not been in remission for at least 5 years at screening;
- •26. Anticipated requirement for the use of pneumatic compression post-operatively or for continued (> 14 days) anticoagulation;
- •27. Severe peripheral vascular disease with ulceration or amputation;
- •28. Any confirmed or suspected acute hepatitis;
- •29. Pregnancy or lactation period in females;
- •30. Severe subjects who are known or suspected to be drug depend
研究者
相似试验
已完成
3 期
A clinical trial to evaluate the clinical effects on safety and efficacy of Kremezin® on suppression of progression of Chronic Renal Failure.CTRI/2010/091/000349G Life Sciences India Pvt Ltd232
进行中（未招募）
不适用
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - NDChronic renal anemiaMedDRA version: 9.1Level: LLTClassification code 10002073Term: Anaemia of chronic diseaseEUCTR2006-004552-21-ITROCHE264
进行中（未招募）
1 期
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - SUSTENTOMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaChronic kidney diseaseEUCTR2006-004552-21-GBF. Hoffmann-La Roche Ltd200
进行中（未招募）
不适用
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - SUSTENTOMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaChronic kidney diseaseEUCTR2006-004552-21-CZF. Hoffmann-La Roche Ltd200
进行中（未招募）
1 期
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysisMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaChronic kidney diseaseEUCTR2006-004552-21-FRF. Hoffmann-La Roche Ltd264