The Örebro Severe Traumatic Brain Injury Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Severe Traumatic Brain Injury, Severe Brain Injury, Ischemic Stroke, Intracerebral Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Örebro Severe Traumatic Brain Injury Registry (ÖrSBID): A Prospective Observational Cohort Study
Overview
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)
Primary outcome measures
- Functional outcome at 12 months [Time frame: Up to 12 months after injury]
Secondary outcome measures (3)
- All-cause mortality [Time frame: From hospital admission (Day 1) through hospital discharge and at 12 months after injury]
- Healthcare utilization after severe brain injury [Time frame: 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 [Time frame: Baseline (within 24 hours of injury) and during the acute hospital phase up to 7 days after injury]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Örebro University Hospital — Örebro
Identifiers
NCT: NCT07398274 · ÖrSBID-01 · 2024-06537-01