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

Completed

• Conditions: Cerebral Venous Thrombosis

• Registration Number: NCT02013635
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (36)

C.H.U. de Grenoble; 🇫🇷 Grenoble, France

Chu D' Angers; 🇫🇷 Angers, France

CH Côte Basque; 🇫🇷 Bayonne, France

Hôpital Pellegrin - CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Estaing; 🇫🇷 Clermont Ferrand, France

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France

C.H. de Compiègne; 🇫🇷 Compiegne, France

Chu Amiens; 🇫🇷 Amiens, France

Ch Victor Dupouy; 🇫🇷 Argenteuil, France

Hôpital Côte de Nacre; 🇫🇷 Caen, France

Hôpital Jean Minjioz; 🇫🇷 Besancon, France

Hôpital Neurologique de Lyon; 🇫🇷 Bron, France

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Hôpital de la Cavale Blanche; 🇫🇷 Brest, France

CHU hopitaux de rouen; 🇫🇷 Rouen, France

CHU-Hôpital Général; 🇫🇷 Dijon, France

Hôpital Guy de Chauliac; 🇫🇷 Montpellier, France

Hôpital Nord de Laënnec; 🇫🇷 Nantes, France

C.H. de Perpignan - Hôpital Saint-Jean; 🇫🇷 Perpignan, France

C.H. Yves Le Foll; 🇫🇷 Saint Brieuc, France

C.H. Saint-Denis; 🇫🇷 Saint Denis, France

C.H.I. Eure-Seine; 🇫🇷 Evreux, France

C.H.U. Limoges; 🇫🇷 Limoges, France

Hôpital de la Timone; 🇫🇷 Marseille, France

C.H. de Meaux; 🇫🇷 Meaux, France

C.H.U de Poitiers; 🇫🇷 Poitiers, France

GH Pitié-Salpêtrière; 🇫🇷 Paris, France

CHRU Bretonneau; 🇫🇷 Tours, France

C.H. de La Rochelle; 🇫🇷 La Rochelle, France

C.H. François Quesnay; 🇫🇷 Mantes La Jolie, France

C.H. de Versailles; 🇫🇷 Le Chesnay, France

Hôpital J. Monod; 🇫🇷 Le Havre, France

G.H.U. Carémeau; 🇫🇷 Nimes, France

G.H. Paris Saint-Joseph; 🇫🇷 Paris, France

CHI de Poissy- site de Poissy; 🇫🇷 Poissy, France

C.H.U de Strasbourg; 🇫🇷 Strasbourg, France