The Örebro Severe Traumatic Brain Injury Registry (ÖrSBID): A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Functional outcome at 12 months
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years
- •Severe traumatic brain injury or other severe brain injury requiring neurointensive or neurointermediate care
- •Admission to Örebro University Hospital
排除标准
- •Age < 16 years < 90 years
- •Non-survivable brain injury
- •Patients not requiring neurointensive or neurointermediate care
- •Declinced consent by patient or legal representative
研究组 & 干预措施
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
结局指标
主要结局
Functional outcome at 12 months
时间窗: 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
次要结局
- 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)
研究者
András Zoltán Buki
Principal Investigator
Region Orebro lan