Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Clinical and Radiological Correlations
PHRC-TVC
Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution
1 other identifier
interventional
232
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 28, 2011
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMay 18, 2026
November 1, 2016
5.2 years
November 28, 2011
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (4)
Evolution of thrombin generation parameters after end of treatment
one year
MR Imaging and Thrombin generation parameters
one year
MR Imaging and D Dimers concentration
one year
Evolution of D Dimers concentration after treatment
one year
Study Arms (1)
Cerebral Venous Thrombosis
EXPERIMENTALInterventions
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)
Imaging performed at baseline and at month 3 (except in case of pregnancy or contraindications) to evaluate cerebral venous thrombosis and parenchymal sequelae.
Standardized neurological and functional evaluations are performed, including NIHSS, Rankin, Glasgow, and Barthel scores at predefined time points.
Eligibility Criteria
You may qualify if:
- Patients over 16 years old hospitalized with an acute cerebral venous thrombosis, confirmed by by cerebral imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Chu Amiens
Amiens, 80054, France
Chu D' Angers
Angers, 49933, France
Ch Victor Dupouy
Argenteuil, 95107, France
CH Côte Basque
Bayonne, 64100, France
Hôpital Jean Minjioz
Besançon, 25030, France
Hôpital Pellegrin - CHU Bordeaux
Bordeaux, 33076, France
Hôpital de la Cavale Blanche
Brest, 29609, France
Hôpital Neurologique de Lyon
Bron, 69677, France
Hôpital Côte de Nacre
Caen, 14033, France
CHU Estaing
Clermont-Ferrand, 63003, France
Hôpitaux Civils de Colmar
Colmar, 68024, France
C.H. de Compiègne
Compiègne, 60321, France
Hôpital Henri Mondor
Créteil, 94010, France
CHU-Hôpital Général
Dijon, 21033, France
C.H.I. Eure-Seine
Évreux, 27000, France
C.H.U. de Grenoble
Grenoble, 38043, France
C.H. de La Rochelle
La Rochelle, 17019, France
C.H. de Versailles
Le Chesnay, 78150, France
Hôpital J. Monod
Le Havre, 76083, France
C.H.U. Limoges
Limoges, 87042, France
C.H. François Quesnay
Mantes-la-Jolie, 78201, France
Hôpital de la Timone
Marseille, 13385, France
C.H. de Meaux
Meaux, 77108, France
Hôpital Guy de Chauliac
Montpellier, 34295, France
Hôpital Nord de Laënnec
Nantes, 44093, France
G.H.U. Carémeau
Nîmes, 30029, France
G.H. Paris Saint-Joseph
Paris, 75014, France
GH Pitié-Salpêtrière
Paris, 75651, France
C.H. de Perpignan - Hôpital Saint-Jean
Perpignan, 66046, France
CHI de Poissy- site de Poissy
Poissy, 78300, France
C.H.U de Poitiers
Poitiers, 86021, France
CHU hopitaux de rouen
Rouen, 76000, France
C.H. Yves Le Foll
Saint-Brieuc, 22027, France
C.H. Saint-Denis
Saint-Denis, 33205, France
C.H.U de Strasbourg
Strasbourg, 67098, France
CHRU Bretonneau
Tours, 37000, France
Related Publications (1)
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.
PMID: 34819911DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
LE CAM DUCHEZ VERONIQUE, MD
CHU HOPITAUX DE ROUEN
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2011
First Posted
December 17, 2013
Study Start
July 1, 2011
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
May 18, 2026
Record last verified: 2016-11