The Norwegian Cerebral Venous Thrombosis Study

Recruiting

• Conditions: Cerebral Venous Sinus Thrombosis; Cerebral Vein Thrombosis

• Registration Number: NCT05021198
• Lead Sponsor: University Hospital, Akershus

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-12-31
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality of CVT in a Norwegian population	Baseline, 3 months, 12 months, 24 months and 5 years	Number dead vs total number of cases

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway