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临床试验/NCT00135863
NCT00135863终止不适用

Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Ribe County Hospital2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2004年5月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
36
试验地点
2
主要终点
Grade of inflammation, local and systemic

研究概览

简要总结

Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double

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

  • End stage renal disease
  • Peritoneal dialysis without complication for minimum of three months
  • 18 years or above
  • Informed consent

排除标准

  • Known coagulatory defects including anticoagulation therapy
  • Known bleeding tendency
  • Peritonitis within two months prior to inclusion
  • Pregnancy
  • Breast feeding
  • Active infection
  • Non-informed consent
  • Allergy to heparin or prior heparin induced thrombocytopenia

结局指标

主要结局

Grade of inflammation, local and systemic

次要结局

  • Change in local cellular distribution
  • Change in local and systemic generation of thrombi
  • Vascular compliance
  • Nutritional state
  • Efficacy of Peritoneal Dialysis

研究者

发起方
Ribe County Hospital
申办方类型
Other

研究点 (2)

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