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临床试验/NCT03864055
NCT03864055已完成不适用

Otogenic Cerebral Sinus Vein Thrombosis in Children: Retrospective Case Series and Associated Thrombophilia

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年12月2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
9
试验地点
1
主要终点
Cultures result

研究概览

简要总结

The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT).

详细描述

Objective

Otogenic Cerebral Sinus Vein Thrombosis (CSVT) is a rare but serious intracranial complication of otitis media in children. The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with otogenic CSVT. Study design: Retrospective case series

研究设计

研究类型
Observational
观察模型
Case Only
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

  • age of 18 years or younger
  • both sexes are included
  • a clinical or radiological finding of mastoiditis in the patient's file
  • Documentation of CSVT in an imaging study, either CT or MRI.
  • Patient's exclusion criteria
  • age above 18 years
  • lack of a clinical or radiological finding of mastoiditis in the patient's file
  • Lack of documentation of CSVT in an imaging study, either CT or MRI.
  • previous unprovoked venous thromboembolism event.

排除标准

  • 未提供

结局指标

主要结局

Cultures result

时间窗: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

the results of cultures from blood, ear secretions, surgery samples, and PCR(polymerize chain reaction assay) will be summarized for the percentage of each pathogen and number of positive results from each type of test

Clinical Presentation

时间窗: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

Clinical presentation signs and symptoms will be collected and a summary will be represented in a table including all subjects

Morbidity and Mortality

时间窗: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

The percentage of Morbidity and Mortality until the end of the follow-up period. Morbidity will include any long term sequelae including permanent neurological deficits, chronic ear inflammation, recurrent mastoiditis, and recurrent thromboembolic events.

Surgical intervention

时间窗: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

Summary of all surgical interventions, and determination of the common types of surgery performed.

Thrombophilia evaluation tests

时间窗: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

Thrombophilia evaluation test results will be collected and a summary will be represented in a table including all subjects

次要结局

  • Imaging Studies results(All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kfir Siag

Dr. Siag Kfir

HaEmek Medical Center, Israel

研究点 (1)

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