The Norwegian Cerebral Venous Thrombosis Study
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: Cerebral Vein Thrombosis, Cerebral Venous Sinus Thrombosis. Базовые параметры: Без ограничений · 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
- Норвегия
- 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
Epidemiology, Clinical and Radiological Presentation and Long-term Prognosis of Cerebral Venous Thrombosis in a Norwegian Population (NoCVT)
Обзор
The NoCVT study will investigate CVT (2014-2023) in a large Norwegian population (\> 3 millions) using several approaches combining existing health registries, clinical databases and new prospectively collected clinical data to explore epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of CVT.
Подробное описание
A retrospective hospital-based chart review will be conducted at 13 different hospitals covering all four health regions and more than 3 million inhabitants in Norway. These 13 hospitals are Akershus University Hospital, Haukeland University Hospital. Oslo University Hospital (Ullevål), Sørlandet Hospital Kristiansand, Drammen Hospital, St.Olavs Hospital, Nordlandsykehuset Bodø, University Hospital of North Norway, Innlandet Hospital Lillehammer, Tønsberg Hospital, Telemark Hospital (Skien), Molde Hospital and Stavanger University Hospital.
A search will be made in the clinical database for patients with the relevant diagnosis of CVT in the period between January 1, 2014, and December 31, 2023. Data from hospital charts will be linked with data from Statistics Norway (SSB), FD-Trygd, and Norwegian Prescription Database (NorPD). Using this combination of clinical data and health registries will make it possible to describe risk factors, clinical and radiological presentation, treatment and short-term outcome in a large Norwegian CVT cohort.
Further, data from hospitals will be linked with data from SSB, FD-Trygd, NorPD, Norwegian Patient Registry (NPR) and Cause of Death Registry (DÅR) up to five years after CVT. Using this methodology will make it possible to investigate overall long-term prognosis and outcomes in terms of mortality, health care utilisation, medication use and working situation up to five years after CVT in a large Norwegian cohort.
Lastly, a prospective follow-up study will include patients that have been diagnosed with CVT at the NoCVT hospitals during 2019-2023. By combining the collected data from the retrospective hospital chart review with the new follow-up interviews and self-reported questionnaires it will be possible to describe quality of life, vocational outcomes, psychological distress, depression, insomnia and disease-related disability in CVT.
Первичные конечные точки
- Mortality of CVT in a Norwegian population [Срок оценки: Baseline, 3 months, 12 months, 24 months and 5 years]
Вторичные конечные точки (12)
- Health care utilisation after CVT [Срок оценки: Baseline to five years]
- Re-admission after CVT [Срок оценки: Baseline to five years]
- New diagnosis after CVT [Срок оценки: Baseline to five years]
- New prescriptions after CVT [Срок оценки: Baseline to five years]
- Nursing home after CVT [Срок оценки: Baseline to five years]
- Use of anti-coagulation in the long-term after CVT [Срок оценки: Baseline to five years]
- Use of anti-platelet therapy in the long-term after CVT [Срок оценки: Baseline to five years]
- Use of painkillers in the long-term after CVT [Срок оценки: Baseline to five years]
- Use of headache prophylactics in the long-term after CVT [Срок оценки: Baseline to five years]
- Use of anti-epileptic drugs in the long-term after CVT [Срок оценки: Baseline to five years]
- Use of anti-depressants in the long-term after CVT [Срок оценки: Baseline to five years]
- Sick-leave after CVT [Срок оценки: Baseline to five years]
Критерии участия
Критерии включения
- A diagnosis of CVT 2014-2023 from the 13 participating primary hospitals
Критерии исключения
- none
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Норвегия · 1 центр
- Akershus University Hospital — Lørenskog
Публикации
- Kristoffersen ES, Harper CE, Vetvik KG, Zarnovicky S, Hansen JM, Faiz KW. Incidence and Mortality of Cerebral Venous Thrombosis in a Norwegian Population. Stroke. 2020 Oct;51(10):3023-3029. doi: 10.1161/STROKEAHA.120.030800. Epub 2020 Sep 4. PMID 32883194
Идентификаторы
NCT: NCT05021198 · NoCVT