The Örebro Severe Traumatic Brain Injury Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAndrás Zoltán Buki
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 16 years
Severe traumatic brain injury or other severe brain injury requiring neurointensive or neurointermediate care
Admission to Örebro University Hospital
Disqualifiers
Age < 16 years < 90 years
Non-survivable brain injury
Patients not requiring neurointensive or neurointermediate care
Declinced consent by patient or legal representative
Trial population
Adult patients with severe traumatic brain injury or other severe brain injuries requiring neurointensive or neurointermediate care at Örebro University Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Severe Brain Injury Cohort
Trial outcomes
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
Time frame
Up to 12 months after injurySecondary outcomes
1
All-cause mortality
All-cause mortality during acute hospitalization and during post-discharge follow-up
Time frame
From hospital admission (Day 1) through hospital discharge and at 12 months after injury2
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
Time frame
From hospital admission (Day 1) through hospital discharge and cumulative readmissions assessed up to 12 months after injury3
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
Time frame
Baseline (within 24 hours of injury) and during the acute hospital phase up to 7 days after injurySponsors and contacts
Click on the lead sponsor to view all of their trials.
András Zoltán Buki
Lead sponsor
Region Orebro lan
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: