Severe Head Injury Brain Analysis

Completed

• Conditions: Brain Injury Traumatic Severe
• Interventions: Procedure: Brain biopsy

• Registration Number: NCT05206760
• Lead Sponsor: Queen Mary University of London

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.

Study Timeline

• Study Start: 2020-07-15
• Status Verified: 2021-05
• Primary Completion: 2021-05-16
• Study Completion: 2021-05-16
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2022-01-24
• Last Update Submitted: 2022-01-24
• Study First Posted: 2022-01-25
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Severe traumatic brain injury -

Exclusion Criteria

Coagulopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trial participants	Brain biopsy	Patients with severe traumatic brain injury requiring craniotomy or ICP bolt insertion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Classification of TBI	immediately after the intervention/procedure/surgery	Classify TBI based on histopathological appearances

Trial Locations

Locations (1)

Royal London Hospital; 🇬🇧 London, United Kingdom