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OpenTrials
Completed

NCT Number: NCT05206760

Severe Head Injury Brain Analysis

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.

Completed

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Key information

Conditions

Brain Injury Traumatic Severe Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal London Hospital

London, E1 1FR, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Severe traumatic brain injury -

Exclusion criteria

Coagulopathy

-

Treatment and study plan

Brain biopsy

Procedure

Biopsy of brain tissue

Primary outcomes

  1. Feasibility of brain biopsy

    Time frame: 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?

  2. Safety of brain biopsy

    Time frame: immediately after the intervention/procedure/surgery

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

Secondary outcomes

  1. Classification of TBI

    Time frame: immediately after the intervention/procedure/surgery

    Classify TBI based on histopathological appearances

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Acronym: SHIBA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2022
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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