NCT00914472Unknown3 期
A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effectiveness of heparin in thrombi formation.
研究概览
简要总结
Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Research that patients agreed to participate and signed the written informed consent;
- •Patients aged over 18 years, both sexes, regardless of color or social class;
- •Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system.
排除标准
- •Hypersensitivity to heparin sodium and / or benzyl alcohol;
- •History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
- •Severe liver disease;
- •Period of gestation;
- •Genetic abnormality of the coagulation system;
- •Multiple trauma;
- •Use of aspirin in high doses (above 200mg per day);
- •Use of glucocorticoids for at least 1 month;
- •Use of other anticoagulants;
- •Submission of a big surgery done less than 15 days;
- •History of persistent hypertension at the end of dialysis than 150/100 mmHg;
- •Indicated doses of heparin 20% above or below 150UI/kg.
结局指标
主要结局
Effectiveness of heparin in thrombi formation.
时间窗: 12 consecutive sessions
During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin.
次要结局
- Evaluation of Anti-Xa(12 consecutive sessions (4 weeks - 3times/week))
- Alteration of the pharmacodynamic parameters.(12 consecutive sessions.)
研究者
研究点 (2)
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