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NCT Number: NCT07398274

The Örebro Severe Traumatic Brain Injury Registry

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.

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Key information

Conditions

Severe Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Brain Injury Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. All-cause mortality

    Time frame: 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

  2. 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

    Healthcare utilization measured as length of intensive care unit stay, total hospital length of stay and number of hospital readmissions

  3. 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

    Concentration of blood- and cerebrospinal fluid-based biomarkers obtained as part of clinical management in patients with severe traumatic brain injury

Study contacts

Contact information is provided by the study sponsor or research team.

András Z Buki, MD, PhD

CONTACT

[email protected]

+46196020555

Sponsors and collaborators

Lead sponsor

András Zoltán Buki

Other Gov

Registry information

Official study title

The Örebro Severe Traumatic Brain Injury Registry (ÖrSBID): A Prospective Observational Cohort Study

Acronym: ÖrSBID

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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