NCT00828776已完成2 期
Clinical Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- TTPA Anti-Xa Adverse Reactions
研究概览
简要总结
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adults of both sexes, regardless of color or social class
- •Age over 18 years with a good clinical medical criteria
- •Patients who agreed to participate and signed the Informed Consent
- •Insufficient patients in chronic renal dialysis schedule (3 times per week)
- •Patients with creatinine clearance <30ml/min
- •Patients with indication for anticoagulation during hemodialysis
排除标准
- •Patients with sensitivity to heparin sodium;
- •Patients with hypersensitivity to benzyl alcohol
- •Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer
- •Patients with a history of peptic ulcer
- •Patients with body mass index greater than 30
- •Cancer patients because of the possibility of compromising the function of the variable coagulation
- •Patients in period of pregnancy or after delivery
- •Patients with genetic abnormality of the clotting system
- •Polytraumatized patients
- •Patients using glucocorticoids for at least 1 month
- •Patients using other anticoagulants
- •Patients with high rate of bleeding
- •Patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery
- •Hypertension above 140/90 mmHg
- •Patients using medications that could affect hemostasis
- •Patients using the following medicines: hormonal anti not including Ketorolac; Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.
结局指标
主要结局
TTPA Anti-Xa Adverse Reactions
时间窗: 12 consecutive sessions of hemodialysis
次要结局
未报告次要终点
研究者
研究点 (2)
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