NCT01352039终止3 期
A Phase III, Non-inferiority, Randomized, Double-blind Trial Comparing Eurofarma Unfractionated Sodium Heparin 5,000 IU to APP Pharmaceuticals Unfractionated Sodium Heparin 5,000 IU in the Thromboprophylaxis of Geriatric Patients Who Underwent Hip Fracture Surgery.
Eurofarma Laboratorios S.A.10 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 544
- 试验地点
- 10
- 主要终点
- The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).
研究概览
简要总结
The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
详细描述
The primary objective of the study is to assess the efficacy of unfractionated heparin sodium of porcine origin (Eurofarma) in the prophylaxis of VTE relative to unfractionated heparin sodium of porcine origin from APP Pharmaceuticals. The primary endpoint will be the frequency of DVT determined by Doppler ultrasound (DUS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be enrolled in this study, eligible patients must meet all criteria below:
- •ICF signing;
- •Aged 60 to 85 years old;
- •Indication of hip orthopedic surgery due to fracture occurred within the last 5 days;
- •Normal coagulation profile or with alterations up to 25% of normal values.
排除标准
- •Patients who meet any of the following criteria will not be eligible for the study:
- •Previous hip surgery;
- •Fracture secondary to the presence of metastasis;
- •Recent traumatic brain, thoracic, or abdominal injury (up to 30 days before study start);
- •Recent occurrence (up to 30 days before study start) of cerebrovascular accident;
- •Serum concentration of hemoglobin below 9 g/dL;
- •Prior occurrence (in the last 5 years) of confirmed or suspected thromboembolic event;
- •Occurrence of major bleeding in the last 6 months (any spontaneous gastrointestinal bleeding; central nervous system bleeding; massive epistaxis, or gum bleeding; gross hematuria, or vaginal bleeding);
- •Confirmed or suspected blood dyscrasia;
- •Diagnosis of neoplasm other than in situ in the last 24 months or any active neoplasm (neoplasms in situ do not prevent patient from participating);
- •Liver or kidney failure;
- •Clinically significant gastrointestinal cardiovascular, neurological disease, or laboratory abnormalities, which at the investigator's opinion, may interfere with individual's participation in the study or with assessment of individual's response to treatment;
- •Hypersensitivity to heparin;
- •Previous use (15 days before study start) of oral anticoagulants or expected use during the study (see Appendix B);
- •Recent participation (previous 12 months) in a clinical trial.
结局指标
主要结局
The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).
时间窗: 6 months
次要结局
- The Secundary endpoint will be proximal and distal DVT(6 months)
研究者
研究点 (10)
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