The Örebro Severe Traumatic Brain Injury Registry (ÖrSBID)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; Intracerebral Hemorrhage; Severe Traumatic Brain Injury; Severe Brain Injury

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Andras Z Buki, MD, PhD; Phone Number: +46196020555; Email: andras.buki@regionorebrolan.se

Study Locations

• Sweden
  • Örebro County
    • Örebro, Örebro County, Sweden, 70182
      • Orebro University Hospital
      • Contact: Andras Z Buki, MD, PhD; Phone Number: +46196020555; Email: andras.buki@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with severe traumatic brain injury or other severe brain injuries requiring neurointensive or neurointermediate care at Örebro University Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: András Zoltán Buki

Study record dates

Study Major Dates

• Study Start (Estimated): February 8, 2026
• Primary Completion (Estimated): February 8, 2028
• Study Completion (Estimated): February 15, 2028

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; severe brain injury; neurocritical care; longitudinal follow-up; neurointensive care; severe traumatic brain injury; multiomics; multimodal monitoring
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Stroke; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Brain Injuries, Traumatic; Brain Injuries; Cerebral Hemorrhage
• Other Study ID Numbers: ÖrSBID-01; 2024-06537-01 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No