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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral Venous Thrombosis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Diagnostic Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of thrombin generation parameters | Evolution from Baseline in thrombin generation parameters and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale) | one year |
| Evolution of D Dimers concentration | Evolution from Baseline in D Dimers concentration and correlation with clinical presentation (initial state and severity with NIH stroke scale and GLASGOW Scale) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of thrombin generation parameters after end of treatment | 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) | one year |
| MR Imaging and Thrombin generation parameters |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LE CAM DUCHEZ VERONIQUE, MD | CHU HOPITAUX DE ROUEN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Amiens | 80054 | France | |||
| Chu D' Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34819911 | Derived | Triquenot Bagan A, Crassard I, Drouet L, Barbieux-Guillot M, Marlu R, Robinet-Borgomino E, Morange PE, Wolff V, Grunebaum L, Klapczynski F, Andre-Kerneis E, Pico F, Martin-Bastenaire B, Ellie E, Menard F, Rouanet F, Freyburger G, Godeneche G, Allano HA, Moulin T, Mourey G, Derex L, Berruyer M, Runavot G, Trichet C, Viader F, Le Querrec A, Husein TT, Cluet-Dennetiere S, Macian-Montoro F, Donnard M, Guillon B, Ternisien C, Zuber M, Laplanche S, Tassan P, Peeltier JY, Canaple S, Roussel B, Gaillard N, Scavazza E, Le Cam Duchez V. Cerebral Venous Thrombosis: Clinical, Radiological, Biological, and Etiological Characteristics of a French Prospective Cohort (FPCCVT)-Comparison With ISCVT Cohort. Front Neurol. 2021 Nov 8;12:753110. doi: 10.3389/fneur.2021.753110. eCollection 2021. |
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|
| Neuroimaging | Other | Imaging performed at baseline and at month 3 (except in case of pregnancy or contraindications) to evaluate cerebral venous thrombosis and parenchymal sequelae. |
|
| Clinical assessments | Other | Standardized neurological and functional evaluations are performed, including NIHSS, Rankin, Glasgow, and Barthel scores at predefined time points. |
|
Number of venous occlusions on MR Imaging and correlation with thrombin generation parameters |
| one year |
| MR Imaging and D Dimers concentration | Number of venous occlusions on MR Imaging and correlation with D Dimers concentration | one year |
| Evolution of D Dimers concentration after treatment | 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) | one year |
| Angers |
| 49933 |
| France |
| Ch Victor Dupouy | Argenteuil | 95107 | France |
| CH Côte Basque | Bayonne | 64100 | France |
| Hôpital Jean Minjioz | Besançon | 25030 | France |
| Hôpital Pellegrin - CHU Bordeaux | Bordeaux | 33076 | France |
| Hôpital de la Cavale Blanche | Brest | 29609 | France |
| Hôpital Neurologique de Lyon | Bron | 69677 | France |
| Hôpital Côte de Nacre | Caen | 14033 | France |
| CHU Estaing | Clermont-Ferrand | 63003 | France |
| Hôpitaux Civils de Colmar | Colmar | 68024 | France |
| C.H. de Compiègne | Compiègne | 60321 | France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| CHU-Hôpital Général | Dijon | 21033 | France |
| C.H.I. Eure-Seine | Évreux | 27000 | France |
| C.H.U. de Grenoble | Grenoble | 38043 | France |
| C.H. de La Rochelle | La Rochelle | 17019 | France |
| C.H. de Versailles | Le Chesnay | 78150 | France |
| Hôpital J. Monod | Le Havre | 76083 | France |
| C.H.U. Limoges | Limoges | 87042 | France |
| C.H. François Quesnay | Mantes-la-Jolie | 78201 | France |
| Hôpital de la Timone | Marseille | 13385 | France |
| C.H. de Meaux | Meaux | 77108 | France |
| Hôpital Guy de Chauliac | Montpellier | 34295 | France |
| Hôpital Nord de Laënnec | Nantes | 44093 | France |
| G.H.U. Carémeau | Nîmes | 30029 | France |
| G.H. Paris Saint-Joseph | Paris | 75014 | France |
| GH Pitié-Salpêtrière | Paris | 75651 | France |
| C.H. de Perpignan - Hôpital Saint-Jean | Perpignan | 66046 | France |
| CHI de Poissy- site de Poissy | Poissy | 78300 | France |
| C.H.U de Poitiers | Poitiers | 86021 | France |
| CHU hopitaux de rouen | Rouen | 76000 | France |
| C.H. Yves Le Foll | Saint-Brieuc | 22027 | France |
| C.H. Saint-Denis | Saint-Denis | 33205 | France |
| C.H.U de Strasbourg | Strasbourg | 67098 | France |
| CHRU Bretonneau | Tours | 37000 | France |
| ID | Term |
|---|---|
| D020767 | Intracranial Thrombosis |
| ID | Term |
|---|---|
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D059906 | Neuroimaging |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003952 | Diagnostic Imaging |
| D003943 | Diagnostic Techniques, Neurological |
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