Registry of Chronic Subdural Hematoma
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: Chronic Subdural Hematoma, Registry. 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
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions: 1. What are the characteristics of patients with CSDH when they are diagnosed? 2. What treatments do patients with CSDH receive? 3. What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status? Participants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.
Подробное описание
Rationale:
Chronic subdural hematoma (CSDH) is a common condition encountered by neurologists and neurosurgeons. While guidelines for the management of CSDH have recently been developed, high-quality evidence to inform these recommendations, particularly level I evidence from randomized clinical trials (RCTs), is awaited. Significant variability in the management of CSDH persists at international, national, and inter-hospital levels. To further refine and implement evidence-based guidelines, a detailed understanding of current clinical practices and their associated outcomes is essential.
Objective:
To describe the baseline characteristics, treatment strategies, and outcomes of patients diagnosed with chronic subdural hematoma.
Study design:
A prospective, observational multicenter cohort study.
Study population:
All adult patients diagnosed with chronic subdural hematoma.
Main study parameters/endpoints:
The primary endpoint is functional outcome, measured by the modified Rankin Scale (mRS) at 3 months. Secondary endpoints, also assessed at 3 months, include recurrence, mortality, complications, hospital length of stay, Markwalder Grading Scale (MGS), modified National Institutes of Health Stroke Scale (mNIHSS), and Telephone Interview for Cognitive Status (TICS).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be treated in accordance with standard clinical practice. Study participation imposes minimal additional burden, consisting of a single telephone interview at three months, estimated to take approximately 10 minutes. The findings from this registry are expected to benefit future CSDH patients by informing evidence-based guidelines and improving care practices.
Первичные конечные точки
- modified Rankin Scale (mRS) score at 3 months following diagnosis [Срок оценки: 3 months following diagnosis]
Вторичные конечные точки (7)
- Recurrence rate within 3 months following diagnosis [Срок оценки: 3 months following diagnosis]
- Mortality within 3 months following diagnosis [Срок оценки: 3 months following diagnosis]
- Complications within 3 months following diagnosis [Срок оценки: 3 months following diagnosis]
- Duration of hospital stay [Срок оценки: 3 months following diagnosis]
- Markwalder Grading Scale (MGS) score at 3 months following diagnosis [Срок оценки: 3 months following diagnosis]
- modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis [Срок оценки: 3 months following diagnosis]
- Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis [Срок оценки: 3 months following diagnosis]
Критерии участия
Критерии включения
- Patients diagnosed with CSDH
- 18 years or older
Критерии исключения
- Patients who do not consent to participate in the registry
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 2 центра
- Amsterdam UMC — Amsterdam
- Erasmus MC — Rotterdam
Идентификаторы
NCT: NCT06759428 · MEC-2021-0629