Cerebral Venous Thrombosis
Conditions
Keywords
cerebral venous thrombosis, thrombin generation, d-dimers, clinical evolution
Brief summary
Cerebral venous thrombosis is considered as a rare type of stroke with an annual incidence of 3 to 4 per million people. It occurs generally in young patients (mean age of occurrence = 40 years) and principally in young females (75%) generally in pregnancy or oral contraceptive use situations. The onset may be acute (less than 2 days), subacute (between 2 and 30 days) or chronic (more than 30 days). The clinical presentation is highly variable and includes patients with only a mild headache, others with focal neurological deficits and a few with a dramatic syndrome and a coma. Moreover the evolution can be very different with unpredictable outcome: more often it is favorable with a low mortality rate, but in some cases it can be a worse course. The aim of this study is to evaluate the correlation of some biological markers: thrombin generation test and D-Dimers (marker of fibrin generation and degradation) with the type of onset or the wide spectrum of clinical presentations or the different modes of evolution. All patients over 16 years ago may be included in the program when CVT diagnosis is proved by magnetic resonance angiography (MRA). For each included patient, there are four blood assays: the first just at the time of diagnosis and before the beginning of treatment, the second before the beginning of the oral anticoagulant treatment. The third assay is done in the third month at the time of a MRA. The last assay is made one month after the end of the anticoagulant treatment or in 12th month after the beginning of the disease if the treatment goes on. For each sample, the investigators perform a thrombin generation test and a D-Dimers measurement.
Interventions
DIAGNOSTIC_TESTBlood samples
Blood samples are collected at the following time points: Day 0 (before anticoagulant therapy) Day 5 (before initiation of oral anticoagulant) Month 3 after inclusion One month after discontinuation of anticoagulant therapy (or at 12 months if therapy continues)
OTHERNeuroimaging
Imaging performed at baseline and at month 3 (except in case of pregnancy or contraindications) to evaluate cerebral venous thrombosis and parenchymal sequelae.
OTHERClinical assessments
Standardized neurological and functional evaluations are performed, including NIHSS, Rankin, Glasgow, and Barthel scores at predefined time points.
Sponsors
University Hospital, Rouen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 16 years old hospitalized with an acute cerebral venous thrombosis, confirmed by by cerebral imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of thrombin generation parameters | one year | Evolution from Baseline in thrombin generation parameters and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale) |
| Evolution of D Dimers concentration | one year | Evolution from Baseline in D Dimers concentration and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of thrombin generation parameters after end of treatment | one year | Evolution from end of treatment in thrombin generation parameters and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale) |
| MR Imaging and Thrombin generation parameters | one year | Number of venous occlusions on MR Imaging and correlation with thrombin generation parameters |
| MR Imaging and D Dimers concentration | one year | Number of venous occlusions on MR Imaging and correlation with D Dimers concentration |
| Evolution of D Dimers concentration after treatment | one year | Evolution from end of treatment in D Dimers concentration and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale) |
Countries
France
Contacts
STUDY_DIRECTORLE CAM DUCHEZ VERONIQUE, MD
CHU HOPITAUX DE ROUEN
Outcome results
None listed