Intracerebral Hemorrhage, Ischemic Stroke, Severe Brain Injury, Severe Traumatic Brain Injury
Conditions
Keywords
severe traumatic brain injury, severe brain injury, neurointensive care, neurocritical care, multimodal monitoring, biomarkers, longitudinal follow-up, multiomics
Brief summary
Traumatic brain injury and other severe brain injuries requiring neurointensive care are associated with high mortality, long-term disability and substantial societal burden. Despite advances in critical care, outcomes after severe brain injury remain difficult to predict and secondary brain injury plays a major role in determining prognosis. The Örebro Severe Brain Injury Database (ÖrSBID) is a prospective observational registry that aims to systematically collect detailed clinical, physiological, imaging and biological data from adult patients with severe brain injury requiring care at the neurointesive care unit or neurointermediate care unit at Örebro University Hospital. The purpose of the registry is to enable deep phenotyping of severe brain injury, improve understanding of secondary injury mechanisms, support outcome prediction and provide a platform for longitudinal follow-up and future research. No experimental interventions are performed as part of the study.
Detailed description
The Örebro Severe Brain Injury Database (ÖrSBIB) is a prospective observational cohort study including adult patients with severe traumatic brain injury and other severe brain injuries of central nervous system origin., such as intracerebral hemorrhage or ischemic stroke, who require neurointensive or neurointermediate care at Örebro University Hospital. Data are collected as part of routine clinical care and include demographic and clinical characteristics, injury severity, neurological assessments, multimodal neuromonitoring data, laboratory results, neuroimaging findings and details of medical and surgical interventions. Biological samples, including blood, cerebrospinal fluid and other clinically indicated specimens are collected according to approved protocols to enable biomarker and multiomics analyses. Patients are followed lonitudinally, including up to 12 months after injury, to assess clinical outcomes, complications, healthcare utilization and long-term consequences of severe brain injury. The study does not involve any experimental treatments or study-specific interventions as patient care is exclusively based on international and national/local guidelines and protocols. All data collection is observational and conducted in accordance with approbal from the Swedish Ethical Review Authority (diary number 2024-06537-01)
Interventions
None listed
Sponsors
András Zoltán Buki
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 16 years * Severe traumatic brain injury or other severe brain injury requiring neurointensive or neurointermediate care * Admission to Örebro University Hospital
Exclusion criteria
* Age \< 16 years \< 90 years * Non-survivable brain injury * Patients not requiring neurointensive or neurointermediate care * Declinced consent by patient or legal representative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome at 12 months | Up to 12 months after injury | Functional outcome assessed up to 12 months after injury using clinical outcome measures and registry-based follow-up data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | From hospital admission (Day 1) through hospital discharge and at 12 months after injury | All-cause mortality during acute hospitalization and during post-discharge follow-up |
| Healthcare utilization after severe brain injury | From hospital admission (Day 1) through hospital discharge and cumulative readmissions assessed up to 12 months after injury | Healthcare utilization measured as length of intensive care unit stay, total hospital length of stay and number of hospital readmissions |
| Concentration of blood and cerebrospinal fluid biomarkers | Baseline (within 24 hours of injury) and during the acute hospital phase up to 7 days after injury | Concentration of blood- and cerebrospinal fluid-based biomarkers obtained as part of clinical management in patients with severe traumatic brain injury |
Countries
Sweden
Contacts
CONTACTAndrás Z Buki, MD, PhD
Outcome results
None listed