Severe Head Injury Brain Analysis
SHIBA
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2021
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 25, 2022
CompletedJanuary 25, 2022
May 1, 2021
10 months
May 20, 2021
January 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (1)
Classification of TBI
immediately after the intervention/procedure/surgery
Study Arms (1)
Trial participants
Patients with severe traumatic brain injury requiring craniotomy or ICP bolt insertion
Interventions
Eligibility Criteria
Patients who have suffered severe traumatic brain injury and require craniotomy or ICP bolt insertion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal London Hospital
London, E1 1FR, United Kingdom
Biospecimen
Brain tissue CSF Blood Urine Saliva Faeces
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris E Uff, PhD
Queen Mary University of London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
January 25, 2022
Study Start
July 15, 2020
Primary Completion
May 16, 2021
Study Completion
May 16, 2021
Last Updated
January 25, 2022
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, 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
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.