The Norwegian Cerebral Venous Thrombosis Study

Study Overview
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Brief Summary
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The NoCVT study will investigate CVT (2010-2019) 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.

Detailed Description
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A retrospective hospital-based chart review will be conducted at eight different hospitals covering all four health regions and more than 3 million inhabitants in Norway. These eight 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, 2010, and December 31, 2019. 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 2015-2019. 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.

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

Conditions
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Cerebral Vein Thrombosis, Cerebral Venous Sinus Thrombosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of CVT 2010-2019 from the 13 participating primary hospitals Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality of CVT in a Norwegian population | Number dead vs total number of cases | Baseline, 3 months, 12 months, 24 months and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care utilisation after CVT | Number of new health care system contacts among CVT cases | Baseline to five years | 
| Re-admission after CVT | Number of new re-admission among CVT cases | Baseline to five years | 
| New diagnosis after CVT | Type of new diagnosis among CVT cases | Baseline to five years | 
| New prescriptions after CVT | Type of new prescriptions among CVT cases | Baseline to five years | 
| Nursing home after CVT | Number of CVT cases in need for nursing home | Baseline to five years | 
| Use of anti-coagulation in the long-term after CVT | Number of cases with CVT using anti-coagulation | Baseline to five years | 
| Use of anti-platelet therapy in the long-term after CVT | Number of cases with CVT using anti-platelet therapy | Baseline to five years | 
| Use of painkillers in the long-term after CVT | Number of cases with CVT using painkillers | Baseline to five years | 
| Use of headache prophylactics in the long-term after CVT | Number of cases with CVT using headache prophylactics | Baseline to five years | 
| Use of anti-epileptic drugs in the long-term after CVT | Number of cases with CVT using anti-epileptic drugs | Baseline to five years | 
| Use of anti-depressants in the long-term after CVT | Number of cases with CVT using anti-epileptic drugs | Baseline to five years | 
| Sick-leave after CVT | Number of cases with CVT on sick-leave | Baseline to five years | 
| Disability pension after CVT | Number of cases with CVT on disability pension | Baseline to five years | 
| Headache after CVT | Type and frequency | Baseline to five years | 
| Headache-related quality of life after CVT | Migraine Disability Assessment Score and Headache Impact Test-6 | Baseline to five years | 
| Seizure/epilepsy after CVT | Type and frequency | Baseline to five years | 
| Epilepsy-related quality of life after CVT | Quality of Life in Epilepsy Inventory-31 | Baseline to five years | 
| Quality of life after CVT | EuroQoL 5 | Baseline to five years | 
| Psychological distress after CVT | Patient Health Questionnaire-9 and Hospital Anxiety and Depression Scale | Baseline to five years | 
| Sleep problems after CVT | Bergen Insomnia Scale | Baseline to five years |