Clinical trial NCT05021198: The Norwegian Cerebral Venous Thrombosis Study
Official title: Epidemiology, Clinical and Radiological Presentation and Long-term Prognosis of Cerebral Venous Thrombosis in a Norwegian Population (NoCVT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Vein Thrombosis
Cerebral Venous Sinus Thrombosis
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Haukeland University Hospital
name: Drammen sykehus
name: Sorlandet Hospital HF
name: St. Olavs Hospital
name: Nordlandssykehuset HF
name: University Hospital of North Norway
name: University of Oslo
name: Rigshospitalet, Denmark
name: Hospital de Santa Maria, Portugal
name: Sykehuset Innlandet HF
name: Molde Hospital
name: Helse Stavanger HF
name: Sykehuset Telemark
name: Sykehuset i Vestfold HF
First posted: 2021-08-25
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: A retrospective hospital-based chart review will be conducted at 13 different hospitals covering approximately 3 million inhabitants in Norway.

More precis, a validated ICD-10 search will be made in the clinical database for patients with the diagnosis of CVT in the period between January 1, 2014, and December 31, 2023. Data from the clinical databases at these hospitals will be linked with the mandatory National Health Registries for baseline data and prospectively collected follow-up data. The National Health Registries involved are Statistics Norway (SSB), Norwegian Prescription Database (NorPD), Norwegian Patient Registry (NPR) and Cause of Death Registry (DÅR).

In addition a clinical follow-up interview will be conducted with emphasis on long-term outcomes.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Mortality of CVT in a Norwegian population
timeFrame: Baseline, 3 months, 12 months, 24 months and 5 years
Secondary outcomes:
measure: Health care utilisation after CVT
timeFrame: Baseline to five years
measure: Re-admission after CVT
timeFrame: Baseline to five years
measure: New diagnosis after CVT
timeFrame: Baseline to five years
measure: New prescriptions after CVT
timeFrame: Baseline to five years
measure: Nursing home after CVT
timeFrame: Baseline to five years
measure: Use of anti-coagulation in the long-term after CVT
timeFrame: Baseline to five years
measure: Use of anti-platelet therapy in the long-term after CVT
timeFrame: Baseline to five years
measure: Use of painkillers in the long-term after CVT
timeFrame: Baseline to five years
measure: Use of headache prophylactics in the long-term after CVT
timeFrame: Baseline to five years
measure: Use of anti-epileptic drugs in the long-term after CVT
timeFrame: Baseline to five years
measure: Use of anti-depressants in the long-term after CVT
timeFrame: Baseline to five years
measure: Sick-leave after CVT
timeFrame: Baseline to five years
measure: Disability pension after CVT
timeFrame: Baseline to five years
measure: Headache after CVT
timeFrame: Baseline to five years
measure: Headache-related quality of life after CVT
timeFrame: Baseline to five years
measure: Seizure/epilepsy after CVT
timeFrame: Baseline to five years
measure: Epilepsy-related quality of life after CVT
timeFrame: Baseline to five years
measure: Quality of life after CVT
timeFrame: Baseline to five years
measure: Psychological distress after CVT
timeFrame: Baseline to five years
measure: Sleep problems after CVT
timeFrame: Baseline to five years
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Espen Saxhaug Kristoffersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.