Traumatic Brain InjuryNCT02021877
Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries
An observational study of Traumatic Brain Injury, run by Turku University Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 396 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2011to Jul 2014
- 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: 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.
Who may be able to join
- 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:
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- All other patients who fulfil the diagnostic criteria for an acute TBI but without any exclusion criteria defined below
- 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)
Who cannot join
- 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
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- 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
- Acute injury of the spinal column and/or cord (including whiplash-injuries of the neck) - superficial soft tissue injuries without neurological symptoms or signs are not an exclusion
- 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.)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries - the TBIcare Project
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.
Read the detailed description
Aim in this study is to collect large amounts of data in adult subject population, who have suffered mild, moderate or severe brain trauma. This data will be added up to the existing large TBI databases from IMPACT as well as to the retrospective brain trauma data sets collected at the Turku University Hospital after the year 1995 and to the prospectively collected existing data set from the University of Cambridge.
Data will contain patient characteristics, injury mechanisms, and patients' physiological status and findings immediately after the incident as well as through the processes of diagnostics, emergency treatment and in-hospital care. All data during these phases will follow the recommendations of Common Data Elements (advanced version) in TBI studies by the IMPACT investigators.
Immediate head CT will be performed according to the existing guidelines, and head MRI with modern techniques as soon as the patient's wellbeing will allow the imaging to be done.
During the intensive care unit (ICU) visit a database of EEG signals will be collected and the relevant information components will be extracted to provide inputs for the care decision algorithm. The aim is to investigate the feasibility of continuous EEG monitoring on the detection of epileptic seizures and other adverse events to enable rapid intervention during the patient's ICU stay and to improve outcome prediction.
The investigators will also search new metabolomic, lipidomic, and genetic biomarkers related to TBIs through analyzing blood samples drawn in different time points.
Based on all these factors, simulation models will be brought up as to help clinicians determine the earliest possible prognosis and to decide, whether patient would benefit from a particular care during the acute phase of a TBI.
- 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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale -extended
•General outcome is assessed using the Glasgow Outcome Scale, extended version (GOS-E)
Measured: Time for outcome assessment is nine months (range 3 to 12 months) from the injury.
Secondary outcomes (4)
QOLIBRI
•The quality of life is assessed using QOLIBRI
Measured: 3 - 12 months from injury
CANTAB
•Cognitive outcome is assessed using CANTAB, an electronic test battery to evaluate neuropsychological function. The subtests used include tests of visual memory, executive function, working memory, planning, attention, semantic/verbal memory, decision-making, and response control
Measured: 3 - 12 months from injury
Rivermead Post Concussion Symptom Questionnaire
•Subjective outcome is assessed using the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ)
Measured: 3 - 12 months from injury
SF-36
•Subjective outcome is assessed using the SF-36 questionnaire
Measured: 3 - 12 months from injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Imperial College London, VTT Technical Research Centre of Finland, GE Healthcare, Kaunas University of Technology
- Responsible party
- Sponsor
- Investigators
- Olli Tenovuo, MD, PhD,, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021877
- Sponsor's protocol ID
- EU funded project nr 270259
- Status last verified
- May 2015
- First submitted
- 20 Dec 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries - the TBIcare Project
- ClinicalTrials.gov ID
- NCT02021877
- Acronym / sponsor ID
- EU funded project nr 270259
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Imperial College London, VTT Technical Research Centre of Finland, GE Healthcare, Kaunas University of Technology
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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.
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.
Detailed description
Aim in this study is to collect large amounts of data in adult subject population, who have suffered mild, moderate or severe brain trauma. This data will be added up to the existing large TBI databases from IMPACT as well as to the retrospective brain trauma data sets collected at the Turku University Hospital after the year 1995 and to the prospectively collected existing data set from the University of Cambridge.
Data will contain patient characteristics, injury mechanisms, and patients' physiological status and findings immediately after the incident as well as through the processes of diagnostics, emergency treatment and in-hospital care. All data during these phases will follow the recommendations of Common Data Elements (advanced version) in TBI studies by the IMPACT investigators.
Immediate head CT will be performed according to the existing guidelines, and head MRI with modern techniques as soon as the patient's wellbeing will allow the imaging to be done.
During the intensive care unit (ICU) visit a database of EEG signals will be collected and the relevant information components will be extracted to provide inputs for the care decision algorithm. The aim is to investigate the feasibility of continuous EEG monitoring on the detection of epileptic seizures and other adverse events to enable rapid intervention during the patient's ICU stay and to improve outcome prediction.
The investigators will also search new metabolomic, lipidomic, and genetic biomarkers related to TBIs through analyzing blood samples drawn in different time points.
Based on all these factors, simulation models will be brought up as to help clinicians determine the earliest possible prognosis and to decide, whether patient would benefit from a particular care during the acute phase of a TBI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow Outcome Scale -extended
Time frame: Time for outcome assessment is nine months (range 3 to 12 months) from the injury.
•General outcome is assessed using the Glasgow Outcome Scale, extended version (GOS-E)
4 secondary outcomes
QOLIBRI
Time frame: 3 - 12 months from injury
CANTAB
Time frame: 3 - 12 months from injury
Rivermead Post Concussion Symptom Questionnaire
Time frame: 3 - 12 months from injury
SF-36
Time frame: 3 - 12 months from injury
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 27 May 2015.
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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.
Olli Tenovuo, MD, PhD, principal investigator
Turku University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Turku University Hospital at 2 sites in 2 countries.
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 9 inclusion and 13 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, 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?
Glasgow Outcome Scale -extended (time frame: Time for outcome assessment is nine months (range 3 to 12 months) from the injury.). 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 27 May 2015.