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
• Status: Completed
• 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
• 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

-

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Severe
• Craniocerebral Trauma
• Wounds and Injuries

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