The Norwegian Cerebral Venous Thrombosis Study

NCT05021198 | Recruiting

• 1 other identifier: NoCVT
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Vein Thrombosis; Cerebral Venous Sinus Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Health care utilisation after CVT

  Baseline to five years

• Re-admission after CVT

  Baseline to five years

• New diagnosis after CVT

  Baseline to five years

• New prescriptions after CVT

  Baseline to five years

• Nursing home after CVT

  Baseline to five years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Oslo University Hospital: collaborator
• Haukeland University Hospital: collaborator
• Drammen sykehus: collaborator
• Sorlandet Hospital HF: collaborator
• St. Olavs Hospital: collaborator
• Nordlandssykehuset HF: collaborator
• University Hospital of North Norway: collaborator
• University of Oslo: collaborator
• Rigshospitalet, Denmark: collaborator
• Hospital de Santa Maria, Portugal: collaborator
• Sykehuset Innlandet HF: collaborator
• Molde Hospital: collaborator
• Helse Stavanger HF: collaborator
• Sykehuset Telemark: collaborator
• Sykehuset i Vestfold HF: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

RECRUITING

Related 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.

  PMID: 32883194 BACKGROUND

MeSH Terms

Conditions

Intracranial Thrombosis

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Study Officials

• Espen Saxhaug Kristoffersen, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Espen Saxhaug Kristoffersen, MD, PhD

CONTACT

e.s.kristoffersen@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: August 25, 2021
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

NO (1)