Brain Injury Traumatic SevereSHIBANCT05206760
Severe Head Injury Brain Analysis
An observational study of Brain Injury Traumatic Severe, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury Traumatic Severe
- What is being tested?
- Brain biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2020to 16 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have suffered severe traumatic brain injury and require craniotomy or ICP bolt insertion.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
A minor amendment was submitted to allow histological and immunohistochemical analysis of the samples.
- Conditions
- Brain Injury Traumatic Severe
- Being tested
- Brain biopsy
- Keywords
- Traumatic Brain Injury, Brain injury classification, Histology
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain biopsyProcedure or surgery
Biopsy of brain tissue
| Study group | Role | What they receive |
|---|---|---|
| Trial participants | Patients with severe traumatic brain injury requiring craniotomy or ICP bolt insertion Receives: Procedure: Brain biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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?
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (1)
Classification of TBI
Classify TBI based on histopathological appearances
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start15 Jul 2020
- Primary completion16 May 2021
- Study completion16 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury Traumatic SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris E Uff, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206760
- Sponsor's protocol ID
- 271662
- Acronym
- SHIBA
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Head Injury Brain Analysis
- ClinicalTrials.gov ID
- NCT05206760
- Acronym / sponsor ID
- SHIBA / 271662
- Conditions
- Brain Injury Traumatic Severe
- Keywords
- Traumatic Brain Injury, Brain injury classification, Histology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial participants | – | Procedure: Brain biopsyPatients with severe traumatic brain injury requiring craniotomy or ICP bolt insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have suffered severe traumatic brain injury and require craniotomy or ICP bolt insertion.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain biopsyBiopsy of brain tissue | Procedure or surgery | Trial participants |
Primary outcome
Feasibility of brain biopsy
Time frame: 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
Time frame: immediately after the intervention/procedure/surgery
Is it safe to perform brain biopsy through ICP bolt or at time of craniotomy in TBI?
1 secondary outcome
Classification of TBI
Time frame: immediately after the intervention/procedure/surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Yes. 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.
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Temporal Interference Stimulation for Disorders of Consciousness
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Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris E Uff, PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury Traumatic Severe, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of brain biopsy (time frame: immediately after the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.