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临床试验/NCT05021198
NCT05021198招募中不适用

Epidemiology, Clinical and Radiological Presentation and Long-term Prognosis of Cerebral Venous Thrombosis in a Norwegian Population (NoCVT)

University Hospital, Akershus1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Mortality of CVT in a Norwegian population

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • A diagnosis of CVT 2014-2023 from the 13 participating primary hospitals

排除标准

  • 未提供

结局指标

主要结局

Mortality of CVT in a Norwegian population

时间窗: Baseline, 3 months, 12 months, 24 months and 5 years

Number dead vs total number of cases

次要结局

  • New diagnosis after CVT(Baseline to five years)
  • Health care utilisation after CVT(Baseline to five years)
  • Use of anti-epileptic drugs in the long-term after CVT(Baseline to five years)
  • Sick-leave after CVT(Baseline to five years)
  • Psychological distress after CVT(Baseline to five years)
  • Sleep problems after CVT(Baseline to five years)
  • New prescriptions after CVT(Baseline to five years)
  • Use of anti-platelet therapy in the long-term after CVT(Baseline to five years)
  • Disability pension after CVT(Baseline to five years)
  • Headache-related quality of life after CVT(Baseline to five years)
  • Seizure/epilepsy after CVT(Baseline to five years)
  • Epilepsy-related quality of life after CVT(Baseline to five years)
  • Re-admission after CVT(Baseline to five years)
  • Use of anti-coagulation in the long-term after CVT(Baseline to five years)
  • Use of painkillers in the long-term after CVT(Baseline to five years)
  • Quality of life after CVT(Baseline to five years)
  • Nursing home after CVT(Baseline to five years)
  • Use of headache prophylactics in the long-term after CVT(Baseline to five years)
  • Use of anti-depressants in the long-term after CVT(Baseline to five years)
  • Headache after CVT(Baseline to five years)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Espen Saxhaug Kristoffersen

Principle Investigator

University Hospital, Akershus

研究点 (1)

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