Severe Head Injury Brain Analysis (SHIBA)

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.

Study Overview

• Status: Completed
• Conditions: Brain Injury Traumatic Severe
• Intervention / Treatment: Procedure: Brain biopsy

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1FR
    • Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have suffered severe traumatic brain injury and require craniotomy or ICP bolt insertion.

Description

Inclusion Criteria: Severe traumatic brain injury -

Exclusion Criteria: Coagulopathy

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trial participants; Patients with severe traumatic brain injury requiring craniotomy or ICP bolt insertion	Procedure: Brain biopsy; Biopsy of brain tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Investigators: Principal Investigator: Chris E Uff, PhD, Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): May 16, 2021
• Study Completion (Actual): May 16, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Histology; Brain injury classification
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: 271662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available to other researchers on request. It is anticipated that this pilot study will result in further trials which will have greater data sharing potential.
• IPD Sharing Time Frame: Data are currently available. They will be available for 10 years (until 01/07/2031)
• IPD Sharing Access Criteria: Apply directly to p.yup@qmul.ac.uk and c.uff@qmul.ac.uk
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No