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 range18 Years
SexALL
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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
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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.