Traumatic Brain Injury Clinical Trial
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Terminated |
NCT03698747 -
Myelin Imaging in Concussed High School Football Players
|
||
Recruiting |
NCT05130658 -
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
|
N/A | |
Recruiting |
NCT04560946 -
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
|
N/A | |
Completed |
NCT05160194 -
Gaining Real-Life Skills Over the Web
|
N/A | |
Recruiting |
NCT02059941 -
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
|
N/A | |
Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
Completed |
NCT04465019 -
Exoskeleton Rehabilitation on TBI
|
||
Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
Suspended |
NCT04244058 -
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
|
Early Phase 1 | |
Completed |
NCT03307070 -
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
|
N/A | |
Recruiting |
NCT04274777 -
The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
|
||
Withdrawn |
NCT04199130 -
Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
|
N/A | |
Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 |