INFORM mi: TBI

• Research type

  Research Study

• Full title

  EXPLORATORY BIOMARKER STUDY IN SUBJECTS WITH HEAD INJURIES

• IRAS ID

  288452

• Contact name

  Antonio Belli

• Contact email

  a.belli@bham.ac.uk

• Sponsor organisation

  Marker AG

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  The purpose of this research study is to characterize biomarkers in buccal (cheek) swabs and compare them to the results obtained by standard neurological tests (concussion or traumatic brain injury evaluations and neuroimaging studies, if they are performed as part of the standard of care treatment) to determine how well the biomarkers can predict concussion or other types of traumatic brain injury. The information will be used to develop a diagnostic test created by Marker Diagnostics (UK) Limited to detect concussion or traumatic brain injury in both children and adults that experience injury to the head. Concussions are also known as mild Traumatic Brain Injury (mTBI). They may occur due to contact injuries to the head, face, or neck. People are at risk of more severe conditions if multiple concussions are sustained in a short period of time.
  Subjects that experienced head injury within 7 days of study entry and age and sex matched controls are eligible.
  The study is a prospective, multi-centre, age and sex matched controlled, non-significant risk (NSR) observational investigation of small non-coding RNAs (sncRNAs) associated with acute head injuries.
  Biomarker presence, levels and change over time will be evaluated in buccal swab samples for 3 months post-injury in up to 150 subjects with TBI and up to 150 sex and age matched control subjects

• REC name

  HSC REC A

• REC reference

  21/NI/0034

• Date of REC Opinion

  11 Jun 2021

• REC opinion

  Further Information Favourable Opinion