Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries (NCT02021877) | Clinical Trial Compass
CompletedNot Applicable
Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries
Finland, United Kingdom396 participantsStarted 2011-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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:
\- All other patients who fulfil the diagnostic criteria for an acute TBI but without any exclusion criteria defined below
Exclusion Criteria:
* 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)
Inclusion criteria for control subjects
* 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)
Exclusion criteria for control subjects
* Age \< 18 years at study entry
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glasgow Outcome Scale -extended
Timeframe: Time for outcome assessment is nine months (range 3 to 12 months) from the injury.