Severe Head Injury Brain Analysis | NCT05206760

Studies
Severe Head Injury Brain Analysis

NCT05206760

Sponsor

Queen Mary University of London

Status

Completed

Last Update Posted

Jan 25, 2022Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Brain Injury Traumatic Severe

Interventions

Brain biopsy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2020Actual

Primary Completion Date

May 16, 2021Actual

Completion Date

May 16, 2021Actual

First Submitted Date

May 20, 2021

First Submission Date that Met QC Criteria

Jan 24, 2022

First Posted Date

Jan 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2022

Last Update Posted Date

Jan 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trial participants		Patients with severe traumatic brain injury requiring craniotomy or ICP bolt insertion	Procedure: Brain biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brain biopsy	Procedure	Biopsy of brain tissue	Trial participants

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Severe traumatic brain injury -

Exclusion Criteria: Coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chris E Uff, PhD	Queen Mary University of London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal London Hospital		London		E1 1FR	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Data are currently available. They will be available for 10 years (until 01/07/2031)

Access Criteria

Apply directly to p.yup@qmul.ac.uk and c.uff@qmul.ac.uk

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided