Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries

NCT02021877 | Completed

• 1 other identifier: EU funded project nr 270259
• Study Type: observational
• Target: 396
• Locations: 2 countries
• Sites: 2

Brief Summary

Adult patients, age ≥ 18 years, with clinically diagnosed mild, moderate or severe brain trauma will be asked to participate in the study. This prospective database will consist of 400 subjects with TBI, 200 from both TUCH and Cambridge Addenbrooke's Hospital. In addition, 100 controls will be recruited, with 50 from both centres.This study is a prospective clinical observational study with detailed data collecting. All patients will be treated according to the accepted, standardized, existing guidelines that are based on national and international recommendations. New treatment interventions will NOT be evaluated during the data acquisition for this study.

Conditions

Traumatic Brain Injury

Keywords

Brain trauma; ICP measurement; cranial CT / MRI; Glasgow Coma Score; acute TBI; EEG; metabolic, proteomic, and genetic biomarkers of TBIs; injury mechanism

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale -extended

  •General outcome is assessed using the Glasgow Outcome Scale, extended version (GOS-E)

  Time for outcome assessment is nine months (range 3 to 12 months) from the injury.

Secondary Outcomes (4)

• QOLIBRI

  3 - 12 months from injury

• CANTAB

  3 - 12 months from injury

• Rivermead Post Concussion Symptom Questionnaire

  3 - 12 months from injury

• SF-36

  3 - 12 months from injury

Study Arms (2)

TBI subjects

Unselected adult patients with acute TBI from the Emergency Departments of the recruiting hospitals

Control subjects

Acute orthopaedic non-trivial trauma that needs either surgery or conservative measures and clinical follow-up (including mere superficial soft tissue injuries)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, age ≥ 18 years, with clinically diagnosed mild, moderate or severe brain trauma will be asked to participate in the study. If such possible subjects are either unconscious, sedated or confused to the extent, that no personal decisions can be drawn, her next of kin will be asked for the permission to include the subject in question to the study. Control group subjects will be patients with acute orthopaedic injuries without any signs of eventual concomitant brain trauma of any degree. The source populations will consist of citizens from the local catchment areas of the participating centres.

You may qualify if:

• Severe or moderate brain trauma subjects with need of ICU care:
• Glasgow Coma Score (GCS) ≤ 8 after the primary stabilization has been performed in the field (= patient not hypoxic or hypotensive) and at least 30 min interval from the moment of injury.
• GCS 9 - 13 and the patient is deteriorating
• The patient has GCS ≤ 13 and has other injuries, which require interventions for hemodynamic or ventilatory incidents
• The patient is in urgent need of neurosurgery (craniotomy, impression skull fracture, severe haemorrhagic contusion, or ICP measurement)
• Moderate or mild brain trauma not in need of ICU care:

You may not qualify if:

• Age \< 18 years at study entry
• Blast-induced TBI
• Perforating or penetrating mechanism of TBI
• Unable to live independently because of a brain disease (= e.g. people with moderate dementia, Down's syndrome, cerebral palsy etc.) or other medical cause before the injury
• TBIs or suspected TBIs not needing cranial CT imaging (excludes the mildest TBIs with negligible risk for incomplete recovery)
• Age ≥ 18 years at study entry
• Acute orthopaedic non-trivial trauma that needs either surgery or conservative measures and clinical follow-up (including mere superficial soft tissue injuries)
• Age \< 18 years at study entry
• Loss of consciousness or amnesia or neurological symptoms or signs in conjunction with the injury, or suspicion of such
• External injuries of the head caused by the acute injury
• Any earlier TBI with loss of consciousness, amnesia or prolonged symptoms (days or more)
• Suspicion or signs of TBI (recent or remote) in brain MRI
• Trauma that needs care or observation at ICU, at any time point during the acute hospital period
• Previous neurological illnesses with obvious permanent alteration in CNS function (cerebral palsy, multiple sclerosis, stroke, encephalitis, degenerative CNS disorders, etc.)

Sponsors & Collaborators

• Turku University Hospital: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Imperial College London: collaborator
• VTT Technical Research Centre of Finland: collaborator
• GE Healthcare: collaborator
• Kaunas University of Technology: collaborator

Study Sites (2)

Turku University Hospital

Turku, 20520, Finland

Location

Cambridge Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Related Links

• Web-pages of the project

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma samples for proteomic, metabolomic and genetic analyses.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Olli Tenovuo, MD, PhD,

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: February 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

GB (1); FI (1)