Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries
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|ClinicalTrials.gov Identifier: NCT02021877|
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : May 27, 2015
|Condition or disease|
|Traumatic Brain Injury|
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 Type :||Observational|
|Actual Enrollment :||396 participants|
|Official Title:||Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries - the TBIcare Project|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||July 2014|
Unselected adult patients with acute TBI from the Emergency Departments of the recruiting hospitals
Acute orthopaedic non-trivial trauma that needs either surgery or conservative measures and clinical follow-up (including mere superficial soft tissue injuries)
- 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)
- QOLIBRI [ Time Frame: 3 - 12 months from injury ]•The quality of life is assessed using QOLIBRI
- CANTAB [ Time Frame: 3 - 12 months from injury ]•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
- Rivermead Post Concussion Symptom Questionnaire [ Time Frame: 3 - 12 months from injury ]•Subjective outcome is assessed using the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ)
- SF-36 [ Time Frame: 3 - 12 months from injury ]•Subjective outcome is assessed using the SF-36 questionnaire
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021877
|Turku University Hospital|
|Turku, Finland, 20520|
|Cambridge Addenbrooke's Hospital|
|Cambridge, United Kingdom|
|Principal Investigator:||Olli Tenovuo, MD, PhD,||Turku University Hospital|