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NCT05206760 Clinical Trial

Severe Head Injury Brain Analysis

Brain Injury Traumatic Severe Clinical Trial

— SHIBA  

Official title:
Severe Head Injury Brain Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05206760
Other study ID # 271662
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date May 16, 2021

Study information
Verified date May 2021
Source Queen Mary University of London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date May 16, 2021
Est. primary completion date May 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Severe traumatic brain injury - Exclusion Criteria: Coagulopathy -

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Brain biopsy
Biopsy of brain tissue

Locations
Country Name City State
United Kingdom Royal London Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of brain biopsy Is it feasible to perform brain biopsy through ICP bolt or at time of craniotomy in TBI in order to obtain diagnostic tissue? immediately after the intervention/procedure/surgery
Primary Safety of brain biopsy Is it safe to perform brain biopsy through ICP bolt or at time of craniotomy in TBI? immediately after the intervention/procedure/surgery
Secondary Classification of TBI Classify TBI based on histopathological appearances immediately after the intervention/procedure/surgery
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