Cerebral Vein ThrombosisNoCVTNCT05021198
The Norwegian Cerebral Venous Thrombosis Study
An observational study of Cerebral Vein Thrombosis and Cerebral Venous Sinus Thrombosis, run by University Hospital, Akershus at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Vein Thrombosis, Cerebral Venous Sinus Thrombosis
- How many people
- 600 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2014to Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- A diagnosis of CVT 2014-2023 from the 13 participating primary hospitals
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Espen Saxhaug Kristoffersen, MD, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lørenskog, 1478
Espen Saxhaug Kristoffersen, MD, PhD, e.s.kristoffersen@medisin.uio.no
About this study
Official title: 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.
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.
- Medical subject headings
- Intracranial Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality of CVT in a Norwegian population
Number dead vs total number of cases
Measured: Baseline, 3 months, 12 months, 24 months and 5 years
Secondary outcomes (20)
Health care utilisation after CVT
Number of new health care system contacts among CVT cases
Measured: Baseline to five years
Re-admission after CVT
Number of new re-admission among CVT cases
Measured: Baseline to five years
New diagnosis after CVT
Type of new diagnosis among CVT cases
Measured: Baseline to five years
New prescriptions after CVT
Type of new prescriptions among CVT cases
Measured: Baseline to five years
Nursing home after CVT
Number of CVT cases in need for nursing home
Measured: Baseline to five years
Use of anti-coagulation in the long-term after CVT
Number of cases with CVT using anti-coagulation
Measured: Baseline to five years
Use of anti-platelet therapy in the long-term after CVT
Number of cases with CVT using anti-platelet therapy
Measured: Baseline to five years
Use of painkillers in the long-term after CVT
Number of cases with CVT using painkillers
Measured: Baseline to five years
Use of headache prophylactics in the long-term after CVT
Number of cases with CVT using headache prophylactics
Measured: Baseline to five years
Use of anti-epileptic drugs in the long-term after CVT
Number of cases with CVT using anti-epileptic drugs
Measured: Baseline to five years
Use of anti-depressants in the long-term after CVT
Number of cases with CVT using anti-epileptic drugs
Measured: Baseline to five years
Sick-leave after CVT
Number of cases with CVT on sick-leave
Measured: Baseline to five years
Disability pension after CVT
Number of cases with CVT on disability pension
Measured: Baseline to five years
Headache after CVT
Type and frequency
Measured: Baseline to five years
Headache-related quality of life after CVT
Migraine Disability Assessment Score and Headache Impact Test-6
Measured: Baseline to five years
Seizure/epilepsy after CVT
Type and frequency
Measured: Baseline to five years
Epilepsy-related quality of life after CVT
Quality of Life in Epilepsy Inventory-31
Measured: Baseline to five years
Quality of life after CVT
EuroQoL 5
Measured: Baseline to five years
Psychological distress after CVT
Patient Health Questionnaire-9 and Hospital Anxiety and Depression Scale
Measured: Baseline to five years
Sleep problems after CVT
Bergen Insomnia Scale
Measured: Baseline to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Jan 2014
- Primary completion31 Dec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- 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, Copenhagen University Hospital, Rigshospitalet, Hospital de Santa Maria, Portugal, Sykehuset Innlandet HF, Molde Hospital, Helse Stavanger HF, Sykehuset Telemark, Sykehuset i Vestfold HF
- Responsible party
- Principal investigator, Espen Saxhaug Kristoffersen, University Hospital, Akershus
- Investigators
- Espen Saxhaug Kristoffersen, MD, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021198
- Sponsor's protocol ID
- NoCVT
- Acronym
- NoCVT
- Status last verified
- Feb 2025
- First submitted
- 27 May 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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