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

Cerebral Venous Thrombosis Clinical Trial

— PHRC-TVC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013635
• Other study ID #: 2010/087/HP
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: November 9, 2016
• Start date: July 2011
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	Chu D' Angers	Angers
France	Ch Victor Dupouy	Argenteuil
France	CH Côte Basque	Bayonne
France	Hôpital Jean Minjioz	Besancon
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	Compiegne
France	Hôpital Henri Mondor	Creteil
France	CHU-Hôpital Général	Dijon
France	C.H.I. Eure-Seine	Evreux
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	Nimes
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	MR Imaging and Thrombin generation parameters	Number of venous occlusions on MR Imaging and correlation with thrombin generation parameters	one year	No
Secondary	MR Imaging and D Dimers concentration	Number of venous occlusions on MR Imaging and correlation with D Dimers concentration	one year	No
Secondary	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	No