The Norwegian Cerebral Venous Thrombosis Study (NoCVT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Vein Thrombosis; Cerebral Venous Sinus Thrombosis

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Espen Saxhaug Kristoffersen, MD, PhD; Email: e.s.kristoffersen@medisin.uio.no

Study Locations

• Norway
  • Lørenskog, Norway, 1478
    • Recruiting
    • Akershus University Hospital
    • Contact: Espen Saxhaug Kristoffersen, MD, PhD; Email: e.s.kristoffersen@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: University of Oslo; Oslo University Hospital; Rigshospitalet, Denmark; University Hospital of North Norway; Helse Stavanger HF; Haukeland University Hospital; Sorlandet Hospital HF; St. Olavs Hospital; Sykehuset Innlandet HF; Hospital de Santa Maria, Portugal; Sykehuset Telemark; Nordlandssykehuset HF; Molde Hospital; Drammen sykehus; Sykehuset i Vestfold HF
• Investigators: Principal Investigator: Espen Saxhaug Kristoffersen, MD, PhD, University Hospital, Akershus

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Intracranial Thrombosis; Thrombosis; Venous Thrombosis; Sinus Thrombosis, Intracranial
• Other Study ID Numbers: NoCVT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No