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NCT Number: NCT05021198

The Norwegian Cerebral Venous Thrombosis Study

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.

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Key information

Conditions

Cerebral Vein Thrombosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Venous Sinus Thrombosis Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism and Thrombosis Intracranial Thrombosis Nervous System Diseases Thromboembolism Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, 1478, Norway

Location status: Recruiting

Location contact

Espen Saxhaug Kristoffersen, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Mortality of CVT in a Norwegian population

    Time frame: Baseline, 3 months, 12 months, 24 months and 5 years

    Number dead vs total number of cases

Secondary outcomes

  1. Health care utilisation after CVT

    Time frame: Baseline to five years

    Number of new health care system contacts among CVT cases

  2. Re-admission after CVT

    Time frame: Baseline to five years

    Number of new re-admission among CVT cases

  3. New diagnosis after CVT

    Time frame: Baseline to five years

    Type of new diagnosis among CVT cases

  4. New prescriptions after CVT

    Time frame: Baseline to five years

    Type of new prescriptions among CVT cases

  5. Nursing home after CVT

    Time frame: Baseline to five years

    Number of CVT cases in need for nursing home

  6. Use of anti-coagulation in the long-term after CVT

    Time frame: Baseline to five years

    Number of cases with CVT using anti-coagulation

  7. Use of anti-platelet therapy in the long-term after CVT

    Time frame: Baseline to five years

    Number of cases with CVT using anti-platelet therapy

  8. Use of painkillers in the long-term after CVT

    Time frame: Baseline to five years

    Number of cases with CVT using painkillers

  9. Use of headache prophylactics in the long-term after CVT

    Time frame: Baseline to five years

    Number of cases with CVT using headache prophylactics

  10. Use of anti-epileptic drugs in the long-term after CVT

    Time frame: Baseline to five years

    Number of cases with CVT using anti-epileptic drugs

  11. Use of anti-depressants in the long-term after CVT

    Time frame: Baseline to five years

    Number of cases with CVT using anti-epileptic drugs

  12. Sick-leave after CVT

    Time frame: Baseline to five years

    Number of cases with CVT on sick-leave

  13. Disability pension after CVT

    Time frame: Baseline to five years

    Number of cases with CVT on disability pension

  14. Headache after CVT

    Time frame: Baseline to five years

    Type and frequency

  15. Headache-related quality of life after CVT

    Time frame: Baseline to five years

    Migraine Disability Assessment Score and Headache Impact Test-6

  16. Seizure/epilepsy after CVT

    Time frame: Baseline to five years

    Type and frequency

  17. Epilepsy-related quality of life after CVT

    Time frame: Baseline to five years

    Quality of Life in Epilepsy Inventory-31

  18. Quality of life after CVT

    Time frame: Baseline to five years

    EuroQoL 5

  19. Psychological distress after CVT

    Time frame: Baseline to five years

    Patient Health Questionnaire-9 and Hospital Anxiety and Depression Scale

  20. Sleep problems after CVT

    Time frame: Baseline to five years

    Bergen Insomnia Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Espen Saxhaug Kristoffersen, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • 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
  • Sykehuset i Vestfold HF
  • University Hospital of North Norway
  • University of Oslo

Registry information

Official study title

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

Acronym: NoCVT

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2021
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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