Clinical trial NCT02013635: Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Clinical and Radiological Correlations
Official title: Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Venous Thrombosis
Keywords: cerebral venous thrombosis
thrombin generation
d-dimers
clinical evolution
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 232
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 16 years old hospitalized with an acute cerebral venous thrombosis

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.


Eligibility criteria: Inclusion Criteria:

* Patients over 16 years old hospitalized with an acute cerebral venous thrombosis, confirmed by by cerebral imaging

Primary outcomes:
measure: Evolution of thrombin generation parameters
timeFrame: one year
measure: Evolution of D Dimers concentration
timeFrame: one year
Secondary outcomes:
measure: Evolution of thrombin generation parameters after end of treatment
timeFrame: one year
measure: MR Imaging and Thrombin generation parameters
timeFrame: one year
measure: MR Imaging and D Dimers concentration
timeFrame: one year
measure: Evolution of D Dimers concentration after treatment
timeFrame: one year
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Angers
country: France
facility: Chu D' Angers
city: Argenteuil
country: France
facility: Ch Victor Dupouy
city: Bayonne
country: France
facility: CH Côte Basque
city: Besancon
country: France
facility: Hôpital Jean Minjioz
city: Bordeaux
country: France
facility: Hôpital Pellegrin - CHU Bordeaux
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Bron
country: France
facility: Hôpital Neurologique de Lyon
city: Caen
country: France
facility: Hôpital Côte de Nacre
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Compiegne
country: France
facility: C.H. de Compiègne
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU-Hôpital Général
city: Evreux
country: France
facility: C.H.I. Eure-Seine
city: Grenoble
country: France
facility: C.H.U. de Grenoble
city: La Rochelle
country: France
facility: C.H. de La Rochelle
city: Le Chesnay
country: France
facility: C.H. de Versailles
city: Le Havre
country: France
facility: Hôpital J. Monod
city: Limoges
country: France
facility: C.H.U. Limoges
city: Mantes La Jolie
country: France
facility: C.H. François Quesnay
city: Marseille
country: France
facility: Hôpital de la Timone
city: Meaux
country: France
facility: C.H. de Meaux
city: Montpellier
country: France
facility: Hôpital Guy de Chauliac
city: Nantes
country: France
facility: Hôpital Nord de Laënnec
city: Nimes
country: France
facility: G.H.U. Carémeau
city: Paris
country: France
facility: G.H. Paris Saint-Joseph
city: Paris
country: France
facility: GH Pitié-Salpêtrière
city: Perpignan
country: France
facility: C.H. de Perpignan - Hôpital Saint-Jean
city: Poissy
country: France
facility: CHI de Poissy- site de Poissy
city: Poitiers
country: France
facility: C.H.U de Poitiers
city: Rouen
country: France
facility: CHU hopitaux de rouen
city: Saint Brieuc
country: France
facility: C.H. Yves Le Foll
city: Saint Denis
country: France
facility: C.H. Saint-Denis
city: Strasbourg
country: France
facility: C.H.U de Strasbourg
city: Tours
country: France
facility: CHRU Bretonneau
Study officials:
affiliation: CHU HOPITAUX DE ROUEN
name: LE CAM DUCHEZ VERONIQUE, MD
role: STUDY_DIRECTOR
References:
citation: 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.