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RecruitingNCT05021198NoCVTUpdated Feb 5, 2025

The Norwegian Cerebral Venous Thrombosis Study

An observational study in Cerebral Vein Thrombosis and Cerebral Venous Sinus Thrombosis, sponsored by University Hospital, Akershus. Recruiting at 1 site in Norway. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by University Hospital, Akershus · Observational

From the registry’s dates

  • Started Jan 2014; still recruiting 12 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
600
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Vein Thrombosis
  • Cerebral Venous Sinus Thrombosis
03

In context

Intracranial Thrombosis

46 studies on the registry are indexed under Intracranial Thrombosis; 15 are open to participants now.

This study's planned enrollment of 600 is above the median of 319 across 26 observational studies indexed under Intracranial Thrombosis.

Browse Intracranial Thrombosis studies →

Lead sponsor

University Hospital, Akershus is the lead sponsor of 125 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality of CVT in a Norwegian population

    Number dead vs total number of cases

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

Secondary outcomes

  1. Health care utilisation after CVT

    Number of new health care system contacts among CVT cases

    Time frame: Baseline to five years

  2. Re-admission after CVT

    Number of new re-admission among CVT cases

    Time frame: Baseline to five years

  3. New diagnosis after CVT

    Type of new diagnosis among CVT cases

    Time frame: Baseline to five years

  4. New prescriptions after CVT

    Type of new prescriptions among CVT cases

    Time frame: Baseline to five years

  5. Nursing home after CVT

    Number of CVT cases in need for nursing home

    Time frame: Baseline to five years

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

    Number of cases with CVT using anti-coagulation

    Time frame: Baseline to five years

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

    Number of cases with CVT using anti-platelet therapy

    Time frame: Baseline to five years

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

    Number of cases with CVT using painkillers

    Time frame: Baseline to five years

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

    Number of cases with CVT using headache prophylactics

    Time frame: Baseline to five years

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

    Number of cases with CVT using anti-epileptic drugs

    Time frame: Baseline to five years

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

    Number of cases with CVT using anti-epileptic drugs

    Time frame: Baseline to five years

  12. Sick-leave after CVT

    Number of cases with CVT on sick-leave

    Time frame: Baseline to five years

  13. Disability pension after CVT

    Number of cases with CVT on disability pension

    Time frame: Baseline to five years

  14. Headache after CVT

    Type and frequency

    Time frame: Baseline to five years

  15. Headache-related quality of life after CVT

    Migraine Disability Assessment Score and Headache Impact Test-6

    Time frame: Baseline to five years

  16. Seizure/epilepsy after CVT

    Type and frequency

    Time frame: Baseline to five years

  17. Epilepsy-related quality of life after CVT

    Quality of Life in Epilepsy Inventory-31

    Time frame: Baseline to five years

  18. Quality of life after CVT

    EuroQoL 5

    Time frame: Baseline to five years

  19. Psychological distress after CVT

    Patient Health Questionnaire-9 and Hospital Anxiety and Depression Scale

    Time frame: Baseline to five years

  20. Sleep problems after CVT

    Bergen Insomnia Scale

    Time frame: Baseline to five years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 32883194 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2014 (actual). Primary completion is estimated for Dec 2026, 155 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2021
First posted
Aug 25, 2021
StartActual
Jan 1, 2014
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jan 2027
Last update
Feb 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05021198
Collaborators
Oslo University Hospital, Haukeland University Hospital, Drammen sykehus, Sorlandet Hospital HF, St. Olavs Hospital, Nordlandssykehuset HF, University Hospital of North Norway, University of Oslo, Rigshospitalet, Denmark, Hospital de Santa Maria, Portugal, Sykehuset Innlandet HF, Molde Hospital, Helse Stavanger HF, Sykehuset Telemark, Sykehuset i Vestfold HF
Responsible party
Espen Saxhaug Kristoffersen (Principle Investigator, University Hospital, Akershus) — Principal investigator
First posted
Aug 25, 2021
Start date
Jan 1, 2014
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Feb 5, 2025

Study contacts

Espen Saxhaug Kristoffersen, MD, PhD
Contact
e.s.kristoffersen@medisin.uio.no
Espen Saxhaug Kristoffersen, MD, PhD
principal investigator · University Hospital, Akershus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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