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临床试验/NCT04845516
NCT04845516已完成不适用

Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective French Multicenter Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
global neurological efficacy of therapeutic apheresis as assessed

研究概览

简要总结

After developing in pediatric hematology and nephrology, therapeutic apheresis is increasingly used in pediatric neurology despite a sparse level of evidence.

There are a few retrospective series with a small number of patients, concerning mainly autoimmune diseases (encephalitis, myasthenia gravis, polyradiculoneuritis).

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.

详细描述

Multicenter medical data collection :

  • Montpellier
  • Toulouse
  • Bordeaux
  • Marseille
  • Nancy
  • Paris Kremlin Bicêtre
  • Paris Robert Debré
  • Paris Necker
  • Paris Trousseau
  • Lyon
  • Besançon
  • Rennes
  • Reims
  • Strasbourg
  • La Réunion
  • Nantes
  • Tours

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

global neurological efficacy of therapeutic apheresis as assessed

时间窗: through study completion, an average of 2 years

lobal neurological efficacy of therapeutic apheresis as assessed by modified rankin score Modifed Rankin score, ranging from 0 (no symptoms) to 6 (death)

次要结局

  • Incidence of therapeutic apheresis adverse events as assessed(through study completion, an average of 2 years)
  • Description of the therapeutic apharesis modalities(through study completion, an average of 2 years)
  • Number of participitants with treatment-related adverse events(during procedures)
  • Incidence of adjuvant treatments(through study completion, an average of 2 years)
  • Incidence of hospitalization in intensive care(through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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