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临床试验/NL-OMON40216
NL-OMON40216招募中不适用

The Thrombin generation Test in Kidney disease Study - 3TKS

Sint Elisabeth Ziekenhuis0 个研究点目标入组 400 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Inclusion criteria for eligibility
  • All participants must be
  • > 18 years of age
  • Willing and able to sign informed consent;Inclusion criteria for CKD Study
  • A potential subject who meets all of the following criteria will be included for participation in the CKD Study:
  • A stable decrease in GFR (for 3 months) with any amount of proteinuria
  • A normal GFR (>60 ml/min) with proteinuria of >2 grams per 24 hours
  • Not hemodialysis-dependent;Inclusion criteria for ESRD Study
  • A potential subject who meets all of the following criteria will be included for participation in the ESRD Study:
  • Non-artificial shunt
  • Stable thrice weekly hemodialysis for more than 3 months (adequate Kt/V)
  • Use of standard dose LMWH, dalteparine <50 kg 2500 EH, >50 kg 5000 EH
  • Any amount of proteinuria;Healthy controls
  • Participants eligible for the control group will have to meet the following criteria
  • A GFR >60
  • No proteinuria
  • No liver disease
  • No anemia or thrombocytopenia
  • No use of hormonal contraceptives
  • Not pregnant
  • No recent trauma or surgery < 4 weeks
  • No medical history of stomach or duodenal ulcers

排除标准

  • Exclusion criteria for CKD and ESRD Study
  • A potential subject who meets any of the following criteria will be excluded from participation in both studies:
  • Patients who use anticoagulants (vitamin K antagonists or therapeutic dose of LMWH) < 4 weeks
  • Patients with trombocytopenia (<100 x 109 / L)
  • Patients who are pregnant or use hormonal anticonceptives
  • Have a known coagulation disorder
  • Have a active malignancy or have been treated for malignancy up to twelve months prior to inclusion date
  • Blood transfusion < 1 week
  • Trauma or surgical procedure < 4 weeks
  • Liver cirrhosis or other liver disease
  • Participation in another research study

研究者

发起方
Sint Elisabeth Ziekenhuis

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