Severe Traumatic Brain InjuryÖrSBIDNCT07398274
The Örebro Severe Traumatic Brain Injury Registry
An observational study of Severe Traumatic Brain Injury and Severe Brain Injury, run by András Zoltán Buki at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Traumatic Brain Injury, Severe Brain Injury, Ischemic Stroke
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 8 Feb 2026to 15 Feb 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with severe traumatic brain injury or other severe brain injuries requiring neurointensive or neurointermediate care at Örebro University Hospital
Who may be able to join
- Age > 16 years
- Severe traumatic brain injury or other severe brain injury requiring neurointensive or neurointermediate care
- Admission to Örebro University Hospital
Who cannot join
- Age < 16 years < 90 years
- Non-survivable brain injury
- Patients not requiring neurointensive or neurointermediate care
- Declinced consent by patient or legal representative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Örebro University Hospital
Örebro, Örebro County, 70182
Andras Z Buki, MD, PhD, +46196020555, andras.buki@regionorebrolan.se
About this study
Official title: The Örebro Severe Traumatic Brain Injury Registry (ÖrSBID): A Prospective Observational Cohort Study
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.
Read the 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)
- Conditions
- Severe Traumatic Brain Injury, Severe Brain Injury, Ischemic Stroke, Intracerebral Hemorrhage
- Keywords
- severe traumatic brain injury, severe brain injury, neurointensive care, neurocritical care, multimodal monitoring, biomarkers, longitudinal follow-up, multiomics
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome at 12 months
Functional outcome assessed up to 12 months after injury using clinical outcome measures and registry-based follow-up data
Measured: Up to 12 months after injury
Secondary outcomes (3)
All-cause mortality
All-cause mortality during acute hospitalization and during post-discharge follow-up
Measured: From hospital admission (Day 1) through hospital discharge and at 12 months after injury
Healthcare utilization after severe brain injury
Healthcare utilization measured as length of intensive care unit stay, total hospital length of stay and number of hospital readmissions
Measured: 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
Measured: Baseline (within 24 hours of injury) and during the acute hospital phase up to 7 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start8 Feb 2026 (estimated)
- Primary completion8 Feb 2028 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- András Zoltán Buki
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, András Zoltán Buki, Region Orebro lan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398274
- Sponsor's protocol ID
- ÖrSBID-01
- Other IDs
- 2024-06537-01
- Acronym
- ÖrSBID
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Örebro Severe Traumatic Brain Injury Registry (ÖrSBID): A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07398274
- Acronym / sponsor ID
- ÖrSBID / ÖrSBID-01
- Conditions
- Severe Traumatic Brain Injury, Severe Brain Injury, Ischemic Stroke, Intracerebral Hemorrhage
- Keywords
- severe traumatic brain injury, severe brain injury, neurointensive care, neurocritical care, multimodal monitoring, biomarkers, longitudinal follow-up, multiomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- András Zoltán BukiOther government
- Study start
- 8 Feb 2026 (estimated)
- Primary completion
- 8 Feb 2028 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe traumatic brain injury or other severe brain injuries requiring neurointensive or neurointermediate care at Örebro University Hospital
Key inclusion criteria (3 listed)
- Age > 16 years
- Severe traumatic brain injury or other severe brain injury requiring neurointensive or neurointermediate care
- Admission to Örebro University Hospital
Key exclusion criteria (4 listed)
- Age < 16 years < 90 years
- Non-survivable brain injury
- Patients not requiring neurointensive or neurointermediate care
- Declinced consent by patient or legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome at 12 months
Time frame: 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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. 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).
Related trials for Severe Traumatic Brain Injury
Not yet recruitingPhase 2/3
Valproic AcId for Traumatic BRAin INjury Trial
Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
RecruitingObservational study
Cortical Spreading Depolarization After Severe Traumatic Brain Injury
Traumatic Brain Injury
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruitingObservational study
Blood NfL and Functional Outcomes After Moderate-to-Severe TBI
Traumatic Brain Injury
Not yet recruitingObservational study
The Systemic Nature of Severe Traumatic Brain Injury
Severe Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Traumatic Brain Injury and Severe Brain Injury, run by András Zoltán Buki at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact András Z Buki, MD, PhD (+46196020555, andras.buki@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome at 12 months (time frame: Up to 12 months after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.