Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Clinical and Radiological Correlations (PHRC-TVC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT02013635
First received: November 28, 2011
Last updated: May 10, 2016
Last verified: May 2016
  Purpose

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.


Condition
Cerebral Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Evolution of thrombin generation parameters [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Evolution of thrombin generation parameters after end of treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of venous occlusions on MR Imaging and correlation with thrombin generation parameters

  • MR Imaging and D Dimers concentration [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of venous occlusions on MR Imaging and correlation with D Dimers concentration

  • Evolution of D Dimers concentration after treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
    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)


Biospecimen Retention:   Samples With DNA
plasma, serum and whole blood

Enrollment: 232
Study Start Date: July 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cerebral Venous Thrombosis
patients over 16 years old with acute cerebral venous thrombosis

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients over 16 years old hospitalized with an acute cerebral venous thrombosis
Criteria

Inclusion Criteria:

  • Patients over 16 years old hospitalized with an acute cerebral venous thrombosis, confirmed by by cerebral imaging
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013635

Locations
France
Chu Amiens
Amiens, France, 80054
Chu D' Angers
Angers, France, 49933
Ch Victor Dupouy
Argenteuil, France, 95107
CH Côte Basque
Bayonne, France, 64100
Hôpital Jean Minjioz
Besancon, France, 25030
Hôpital Pellegrin - CHU Bordeaux
Bordeaux, France, 33076
Hôpital de la Cavale Blanche
Brest, France, 29609
Hôpital Neurologique de Lyon
Bron, France, 69677
Hôpital Côte de Nacre
Caen, France, 14033
CHU Estaing
Clermont Ferrand, France, 63003
Hôpitaux Civils de Colmar
Colmar, France, 68024
C.H. de Compiègne
Compiegne, France, 60321
Hôpital Henri Mondor
Creteil, France, 94010
CHU-Hôpital Général
Dijon, France, 21033
C.H.I. Eure-Seine
Evreux, France, 27000
C.H.U. de Grenoble
Grenoble, France, 38043
C.H. de La Rochelle
La Rochelle, France, 17019
C.H. de Versailles
Le Chesnay, France, 78150
Hôpital J. Monod
Le Havre, France, 76083
C.H.U. Limoges
Limoges, France, 87042
C.H. François Quesnay
Mantes La Jolie, France, 78201
Hôpital de la Timone
Marseille, France, 13385
C.H. de Meaux
Meaux, France, 77108
Hôpital Guy de Chauliac
Montpellier, France, 34295
Hôpital Nord de Laënnec
Nantes, France, 44093
G.H.U. Carémeau
Nimes, France, 30029
G.H. Paris Saint-Joseph
Paris, France, 75014
GH Pitié-Salpêtrière
Paris, France, 75651
C.H. de Perpignan - Hôpital Saint-Jean
Perpignan, France, 66046
CHI de Poissy- site de Poissy
Poissy, France, 78300
C.H.U de Poitiers
Poitiers, France, 86021
CHU hopitaux de rouen
Rouen, France, 76000
C.H. Yves Le Foll
Saint Brieuc, France, 22027
C.H. Saint-Denis
Saint Denis, France, 33205
C.H.U de Strasbourg
Strasbourg, France, 67098
CHRU Bretonneau
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Study Director: LE CAM DUCHEZ VERONIQUE, MD CHU HOPITAUX DE ROUEN
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02013635     History of Changes
Other Study ID Numbers: 2010/087/HP 
Study First Received: November 28, 2011
Last Updated: May 10, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
cerebral venous thrombosis
thrombin generation
d-dimers
clinical evolution

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Thrombin
Coagulants
Hemostatics

ClinicalTrials.gov processed this record on May 26, 2016