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临床试验/NCT01049711
NCT01049711已完成不适用

Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis

Mahidol University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
1
主要终点
The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.

研究概览

简要总结

To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.

详细描述

In Thailand, the studies that were conducted to find the most useful target Hb have not included the cost effectiveness and/or cost utility analyses. The level at which quality of life is maximized and risk is minimized would be the optimal target. Dialysis patients carry higher risk of death than general population. Anemia is the common complication found in dialysis patients that could lead to mortality. Risk of anemia is occurred in HD patients more than CAPD patients because blood loss is less marked and residual renal function maybe better preserved in patients who receive peritoneal dialysis.Although EPO has been included in the National List of Essential Drugs (NLED) for the treatment of anemia caused by end stage renal disease for maintaining the target hemoglobin but the cost of EPO is so expensive. Cost utility analysis is economic technique for assessing the efficiency of healthcare intervention measuring combined outcomes as the effectiveness, i.e., survival and quality of life in combination as quality adjusted life years (QALYs).This study is a benefit measure at the care giving level by using as a part of planning patient management program and at the policy level for decision making.

研究设计

研究类型
Observational
时间视角
Prospective

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

入选标准

  • Patients use EPO at least 6 months with titration of EPO therapy is permitted

排除标准

  • Patients under 18 years old.
  • Patients who have blood transfusion for anemic treatment within 6 months before EPO treatment and before the study starts
  • Patients who change the modality of dialysis
  • Patients who switch to other anemia treatment method between the study
  • Patients who cannot answer the questionnaire and are not willing to participate in the study

研究组 & 干预措施

erythropoietin

干预措施: erythropoietin (Drug)

结局指标

主要结局

The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.

时间窗: 1 year

Cost of HD patients who use EPO to maintain the Hb target level.

时间窗: 1 year

次要结局

  • The incremental cost-effectiveness ratio (calculated as the ratio between the incremental differences in costs and QALYs associated with 2 alternative treatments) of EPO at the different Hb target levels in HD patients in routine clinical practice.(lifetime horizon (Economic evaluation term))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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