Набор скоро начнётся NCT07398274

The Örebro Severe Traumatic Brain Injury Registry

— Наблюдательное Severe Traumatic Brain Injury Severe Brain Injury Ischemic Stroke Intracerebral Hemorrhage

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Severe Traumatic Brain Injury, Severe Brain Injury, Ischemic Stroke, Intracerebral Hemorrhage. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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)

Первичные конечные точки

Functional outcome at 12 months [Срок оценки: Up to 12 months after injury]

Вторичные конечные точки (3)

All-cause mortality [Срок оценки: From hospital admission (Day 1) through hospital discharge and at 12 months after injury]
Healthcare utilization after severe brain injury [Срок оценки: 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 [Срок оценки: Baseline (within 24 hours of injury) and during the acute hospital phase up to 7 days after injury]

Критерии участия

Критерии включения

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