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临床试验/NCT05206760
NCT05206760已完成不适用

Severe Head Injury Brain Analysis

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年7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
25
试验地点
1
主要终点
Feasibility of brain biopsy

研究概览

简要总结

Safety and feasibility study investigating brain biopsy in severe head injury. When a patient undergoes craniotomy or ICP bolt insertion for trauma, a biopsy of brain tissue is taken.

Blood, saliva, urine and faeces samples are also taken for 7 days following the brain biopsy.

CSF is collected if a CSF drainage device is used.

详细描述

A minor amendment was submitted to allow histological and immunohistochemical analysis of the samples.

研究设计

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

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

  • Severe traumatic brain injury -

排除标准

  • Coagulopathy

结局指标

主要结局

Feasibility of brain biopsy

时间窗: immediately after the intervention/procedure/surgery

Is it feasible to perform brain biopsy through ICP bolt or at time of craniotomy in TBI in order to obtain diagnostic tissue?

Safety of brain biopsy

时间窗: immediately after the intervention/procedure/surgery

Is it safe to perform brain biopsy through ICP bolt or at time of craniotomy in TBI?

次要结局

  • Classification of TBI(immediately after the intervention/procedure/surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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