The Norwegian Cerebral Venous Thrombosis Study

Cerebral Vein Thrombosis Clinical Trial

— NoCVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021198
• Other study ID #: NoCVT
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: University Hospital, Akershus
• Contact: Espen Saxhaug Kristoffersen, MD, PhD
• Email: e.s.kristoffersen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cerebral Vein Thrombosis
• Cerebral Venous Sinus Thrombosis
• Sinus Thrombosis, Intracranial
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (16)

Lead Sponsor	Collaborator
University Hospital, Akershus	Drammen sykehus, Haukeland University Hospital, Helse Stavanger HF, Hospital de Santa Maria, Portugal, Molde Hospital, Nordlandssykehuset HF, Oslo University Hospital, Rigshospitalet, Denmark, Sorlandet Hospital HF, St. Olavs Hospital, Sykehuset Innlandet HF, Sykehuset Telemark, University Hospital of North Norway, University of Oslo, Vestfold

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

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