NCT07398274

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Feb 2028

First Submitted

Initial submission to the registry

January 27, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 8, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2028

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 27, 2026

Last Update Submit

February 4, 2026

Conditions

Severe Traumatic Brain InjurySevere Brain InjuryIschemic StrokeIntracerebral Hemorrhage

Keywords

severe traumatic brain injurysevere brain injuryneurointensive careneurocritical caremultimodal monitoringbiomarkerslongitudinal follow-upmultiomics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • All-cause mortality

    From hospital admission (Day 1) through hospital discharge and at 12 months after injury

  • Healthcare utilization after severe brain injury

    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

    Baseline (within 24 hours of injury) and during the acute hospital phase up to 7 days after injury

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age \> 16 years
  • Severe traumatic brain injury or other severe brain injury requiring neurointensive or neurointermediate care
  • Admission to Örebro University Hospital

You may not qualify if:

  • Age \< 16 years \< 90 years
  • Non-survivable brain injury
  • Patients not requiring neurointensive or neurointermediate care
  • Declinced consent by patient or legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University Hospital

Örebro, Örebro County, 70182, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain InjuriesIschemic StrokeCerebral Hemorrhage

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesStrokeCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

András Z Buki, MD, PhD

CONTACT

+46196020555andras.buki@regionorebrolan.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 9, 2026

Study Start

February 8, 2026

Primary Completion (Estimated)

February 8, 2028

Study Completion (Estimated)

February 15, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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).

Locations

SE(1)