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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-06537-01 | Other Identifier | Swedish Ethical Review Authority |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Brain Injury Cohort | Adult patients with severe traumatic brain injury or other severe brain injuries requiring neurointensive or neurointermediate care at Örebro University Hospital |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome at 12 months | Functional outcome assessed up to 12 months after injury using clinical outcome measures and registry-based follow-up data | Up to 12 months after injury |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality during acute hospitalization and during post-discharge follow-up | From hospital admission (Day 1) through hospital discharge and at 12 months after injury |
| Healthcare utilization after severe brain injury |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with severe traumatic brain injury or other severe brain injuries requiring neurointensive or neurointermediate care at Örebro University Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| András Z Buki, MD, PhD | Contact | +46196020555 | andras.buki@regionorebrolan.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University Hospital | Örebro | Örebro County | 70182 | Sweden |
Individual participant data will not be shared outside of the research group and will be pseudonymized as per EU and Swedish General Data Protection Regulation (GDPR).
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D000083242 | Ischemic Stroke |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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Biological sampled, including blood and cerebrospinal fluid collected as part of routine clinical care, are retained for biomarker, genetic and multi-omics analyses related to severe brain injury
Healthcare utilization measured as length of intensive care unit stay, total hospital length of stay and number of hospital readmissions
| From hospital admission (Day 1) through hospital discharge and cumulative readmissions assessed up to 12 months after injury |
| Concentration of blood and cerebrospinal fluid biomarkers | Concentration of blood- and cerebrospinal fluid-based biomarkers obtained as part of clinical management in patients with severe traumatic brain injury | Baseline (within 24 hours of injury) and during the acute hospital phase up to 7 days after injury |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |