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临床试验/NL-OMON34390
NL-OMON34390已完成不适用

The microcirculation in children treated with extracorporeal membrane oxygenation; an observational longitudinal study - Microcirculatory changes during ECMO

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 90 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
已完成
入组人数
90

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
2 至 17(—)

入选标准

  • Group 1 & 2:
  • -Patients admitted to the (neonatal and/or pediatric) IC of Erasmus MC-Sophia, in need of ECMO either due to pathology for which they are primarily admitted or due to secondary pathology which originates during their admittance in the IC.
  • - Parental informed consent before ECMO obtained by using the short patient information letter (PIF no. 1; see Ch. 8.2 research protocol) and parental informed consent obtained within 24h after ECMO start obtained by using the regular PIF (PIF no. 2; see Ch. 8.2 research protocol)
  • -Patients in group 2 will be matched 1 on 1 to patients in group 1 for gender and age (± 6 months);Group 3:
  • - Term patients admitted to the IC of Erasmus MC-Sophia in need of RBC transfusion after surgery (e.g. patients after craniofacial surgery, patients after cardiac surgery)
  • - Parental informed consent
  • - Patients in group 3 will be matched 1 on 1 to patients in group 1 for gender and age (± 1 month)

排除标准

  • Group 1 & 2:
  • - Age * 18 years
  • - Rapid response ECMO outside the IC of Erasmus MC-Sophia
  • - Transfer on ECMO to the IC of Erasmus MC-Sophia (including the dept. of thoracic surgery of Erasmus MC-Sophia)
  • - Unsuccessful cannulation and/or inability to generate sufficient blood flow
  • - ECMO exclusion criteria (e.g. weight < 2kg., irreversible pathology);Group 3:
  • - Preterm infants
  • - Age * 18 years
  • - RBC transfusion by irradiated blood cell products
  • - RBC transfusion of blood cell savers
  • - Term patients diagnosed with malignancy (hematologic and/or solid organ)
  • - Term patients diagnosed with hemoglobinopathy of any kind
  • - Term patients diagnosed with bone marrow disease of any kind
  • - Cardiopulmonary resuscitation and subsequent therapeutic hypothermia
  • - Severe pathology which imply abstinence of therapy

研究者

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