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临床试验/NCT02607111
NCT02607111已完成4 期

A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients: A Prospective Study

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
15
试验地点
1
主要终点
The mean dalteparin dose for the daily home hemodialysis patients

研究概览

简要总结

This study evaluates the optimal dosage and safety of Dalteparin when used as an anticoagulant for hemodialysis therapies.

详细描述

Routine anticoagulation is required during hemodialysis treatments. In North America, the anticoagulant of choice for hemodialysis therapies is unfractionated heparin (UFH), whereas in Western Europe, it is low molecular weight heparin (LMWH). Dalteparin is more commonly used in Canada and has been approved for use in the in-centre thrice-weekly hemodialysis population at a fixed dose of 5000 units. However, there have been no published studies to assess the use of dalteparin in home quotidian and/or nocturnal hemodialysis therapies. Patients on frequent hemodialysis or nocturnal hemodialysis in the home will be converted to Dalteparin from Heparin for 4 weeks to evaluate the optimal dosage and to assess its safety in this population

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Currently undergoing short-hour daily and nocturnal hemodialysis through the home dialysis program at London Health Sciences Centre.

排除标准

  • Patients with increased bleeding risks
  • Currently on full dose anticoagulants
  • Active bleeding
  • Diabetic retinopathy
  • Active cancer receiving treatment within the past 6 months

研究组 & 干预措施

open label

Experimental

Dalteparin injected as a bolus into the arterial port of the hemodialysis machine every dialysis session for four weeks

干预措施: Dalteparin (Drug)

结局指标

主要结局

The mean dalteparin dose for the daily home hemodialysis patients

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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