Severe Head Injury Brain Analysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05206760

Acronym

SHIBA

Enrollment

Registered

2022-01-25

Start date

2020-07-15

Completion date

2021-05-16

Last updated

2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury Traumatic Severe

Keywords

Traumatic Brain Injury, Brain injury classification, Histology

Brief 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.

Detailed description

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

Interventions

PROCEDUREBrain biopsy

Biopsy of brain tissue

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Severe traumatic brain injury -

Exclusion criteria

Coagulopathy \-

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of brain biopsy	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	immediately after the intervention/procedure/surgery	Is it safe to perform brain biopsy through ICP bolt or at time of craniotomy in TBI?

Secondary

Measure	Time frame	Description
Classification of TBI	immediately after the intervention/procedure/surgery	Classify TBI based on histopathological appearances

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026