A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 152
- 试验地点
- 17
- 主要终点
- Mean Percent of Successful HD Sessions
研究概览
简要总结
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic renal failure on hemodialysis
排除标准
- •significant comorbidities that would prevent a patient from completing the trial
研究组 & 干预措施
Fragmin
Fragmin given according to the flexible dosing regimen outlined in the protocol
干预措施: Fragmin (Drug)
结局指标
主要结局
Mean Percent of Successful HD Sessions
时间窗: 20 HD sessions (up to 4 hours)
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
次要结局
- Mean Percent of HD Sessions With an Acceptable Dose(20 HD sessions (up to 4 hours))