The Norwegian Cerebral Venous Thrombosis Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Vein Thrombosis, Cerebral Venous Sinus Thrombosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Epidemiology, Clinical and Radiological Presentation and Long-term Prognosis of Cerebral Venous Thrombosis in a Norwegian Population (NoCVT)
Overview
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.
Primary outcome measures
- Mortality of CVT in a Norwegian population [Time frame: Baseline, 3 months, 12 months, 24 months and 5 years]
Secondary outcome measures (12)
- Health care utilisation after CVT [Time frame: Baseline to five years]
- Re-admission after CVT [Time frame: Baseline to five years]
- New diagnosis after CVT [Time frame: Baseline to five years]
- New prescriptions after CVT [Time frame: Baseline to five years]
- Nursing home after CVT [Time frame: Baseline to five years]
- Use of anti-coagulation in the long-term after CVT [Time frame: Baseline to five years]
- Use of anti-platelet therapy in the long-term after CVT [Time frame: Baseline to five years]
- Use of painkillers in the long-term after CVT [Time frame: Baseline to five years]
- Use of headache prophylactics in the long-term after CVT [Time frame: Baseline to five years]
- Use of anti-epileptic drugs in the long-term after CVT [Time frame: Baseline to five years]
- Use of anti-depressants in the long-term after CVT [Time frame: Baseline to five years]
- Sick-leave after CVT [Time frame: Baseline to five years]
Eligibility criteria
Inclusion criteria
- A diagnosis of CVT 2014-2023 from the 13 participating primary hospitals
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Akershus University Hospital — Lørenskog
Publications
- 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
Identifiers
NCT: NCT05021198 · NoCVT