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COMPLETED
NCT02013635
NA

Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Clinical and Radiological Correlations

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

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.

Official title: Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

232

Start Date

2011-07

Completion Date

2016-09

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Blood 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)

OTHER

Neuroimaging

Imaging performed at baseline and at month 3 (except in case of pregnancy or contraindications) to evaluate cerebral venous thrombosis and parenchymal sequelae.

OTHER

Clinical assessments

Standardized neurological and functional evaluations are performed, including NIHSS, Rankin, Glasgow, and Barthel scores at predefined time points.

Locations (36)

Chu Amiens

Amiens, France

Chu D' Angers

Angers, France

Ch Victor Dupouy

Argenteuil, France

CH Côte Basque

Bayonne, France

Hôpital Jean Minjioz

Besançon, France

Hôpital Pellegrin - CHU Bordeaux

Bordeaux, France

Hôpital de la Cavale Blanche

Brest, France

Hôpital Neurologique de Lyon

Bron, France

Hôpital Côte de Nacre

Caen, France

CHU Estaing

Clermont-Ferrand, France

Hôpitaux Civils de Colmar

Colmar, France

C.H. de Compiègne

Compiègne, France

Hôpital Henri Mondor

Créteil, France

CHU-Hôpital Général

Dijon, France

C.H.I. Eure-Seine

Évreux, France

C.H.U. de Grenoble

Grenoble, France

C.H. de La Rochelle

La Rochelle, France

C.H. de Versailles

Le Chesnay, France

Hôpital J. Monod

Le Havre, France

C.H.U. Limoges

Limoges, France

C.H. François Quesnay

Mantes-la-Jolie, France

Hôpital de la Timone

Marseille, France

C.H. de Meaux

Meaux, France

Hôpital Guy de Chauliac

Montpellier, France

Hôpital Nord de Laënnec

Nantes, France

G.H.U. Carémeau

Nîmes, France

G.H. Paris Saint-Joseph

Paris, France

GH Pitié-Salpêtrière

Paris, France

C.H. de Perpignan - Hôpital Saint-Jean

Perpignan, France

CHI de Poissy- site de Poissy

Poissy, France

C.H.U de Poitiers

Poitiers, France

CHU hopitaux de rouen

Rouen, France

C.H. Yves Le Foll

Saint-Brieuc, France

C.H. Saint-Denis

Saint-Denis, France

C.H.U de Strasbourg

Strasbourg, France

CHRU Bretonneau

Tours, France