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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT02013635
First received: November 28, 2011
Last updated: June 18, 2014
Last verified: June 2014
  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


Estimated Enrollment: 250
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

Contacts
Contact: LE CAM DUCHEZ VERONIQUE, MD 0232881397 Veronique.Le-Cam-Duchez@chu-rouen.fr
Contact: TRIQUENOT BAGAN AUDE, MD 0232888170 aude.triquenot-bagan@chu-rouen.fr

Locations
France
Chu Amiens Not yet recruiting
Amiens, France, 80054
Contact: GODEFROY OLIVIER, PHD       godefroy.olivier@chu-amiens.fr   
Principal Investigator: CANAPLE SANDRINE, MD         
Principal Investigator: ROUSSEL BERTRAND, MD         
Chu D' Angers Not yet recruiting
Angers, France, 49933
Contact: MARC GUILLAUME, MD       gumarc@chu-angers.fr   
Principal Investigator: MARC GUILLAUME, MD         
Principal Investigator: MACCHI LAURENT, MD         
Ch Victor Dupouy Recruiting
Argenteuil, France, 95107
Contact: LE GUILLOU JOHAN, MD       johan.leguilloux@ch-argenteuil.fr   
Principal Investigator: TRICHET CATHERINE, MD         
CH Côte Basque Recruiting
Bayonne, France, 64100
Contact: ELIE EMMANUEL, MD       eellie001@ch-cotebasque.fr   
Principal Investigator: ELIE EMMANUEL, MD         
Principal Investigator: DUCOUT LOUIS, MD         
Hôpital Jean Minjioz Recruiting
Besancon, France, 25030
Contact: MOULIN THIERRY, PHD       tmoulin@univ-fcomte.fr   
Principal Investigator: MOULIN THIERRY, MD         
Principal Investigator: RACADOT EVELYNE, MD         
Hôpital Pellegrin - CHU Bordeaux Recruiting
Bordeaux, France, 33076
Contact: ROUANET FRANCOIS, MD       francois.rouanet@chu-bordeaux.fr   
Principal Investigator: ROUANET FRANCOIS, MD         
Principal Investigator: FREYBURGER GENEVIEVE, MD         
Hôpital de la Cavale Blanche Not yet recruiting
Brest, France, 29609
Contact: TIMSIT SERGE, PHD       serge.timsit@chu-brest.fr   
Principal Investigator: PAN-PETESCH BRIGITTE, MD         
Hôpital Neurologique de Lyon Recruiting
Bron, France, 69677
Contact: DEREX LAURENT, MD       laurent.derex@chu-lyon.fr   
Principal Investigator: DEREX LAURENT, MD         
Principal Investigator: BERRUYER MICHELINE, MD         
Hôpital Côte de Nacre Recruiting
Caen, France, 14033
Contact: VIADER FAUSTO, PHD       viader-f@chu-caen.fr   
Principal Investigator: VIADER FAUSTO, PHD         
Principal Investigator: LE QUERREC AGNES, MD         
CHU Estaing Not yet recruiting
Clermont Ferrand, France, 63003
Contact: FERRIER ANNA, MD       aferrier@chu-clermont-ferrand.fr   
Principal Investigator: FERRIER ANNA, MD         
Principal Investigator: BERGER MARC, MD         
Hôpitaux Civils de Colmar Not yet recruiting
Colmar, France, 68024
Contact: VUILLEMENT FRANCIS, MD       francis.vuillemet@ch-colmar.fr   
Principal Investigator: VUILLEMET FRANCIS, MD         
Principal Investigator: DUGAY ARENTZ MARIE HELENE, MD         
Principal Investigator: MAZURIER ISABELLE, MD         
C.H. de Compiègne Recruiting
Compiegne, France, 60321
Contact: HUSEIN THOMAS TAREK, MD       t.husein@ch-compiegne.fr   
Principal Investigator: CLUET DENNETIERE SOPHIE, MD         
Hôpital Henri Mondor Not yet recruiting
Creteil, France, 94010
Contact: HOSSEINI HASSAN, MD       hassan.hosseini@hmn.aphp.fr   
Principal Investigator: HOSSEINI HASSAN, MD         
Principal Investigator: MATHERON CATHERINE, MD         
CHU-Hôpital Général Not yet recruiting
Dijon, France, 21033
Contact: GIROUD MAURICE, PHD       maurice.giroud@chu-dijon.fr   
Principal Investigator: GIROUD MAURINE, PHD         
Principal Investigator: DE MAISTRE EMMANUEL, MD         
C.H.I. Eure-Seine Not yet recruiting
Evreux, France, 27000
Contact: KORT LOTFI, MD       lotfi.kort@chi-eureseine.fr   
Principal Investigator: KORT LOTFI, MD         
Principal Investigator: NOPPE ISABELLE, MD         
C.H.U. de Grenoble Recruiting
Grenoble, France, 38043
Contact: DETANTE OLIVIER, MD       Odetante@chu-grenoble.fr   
Principal Investigator: DETANTE OLIVIER, MD         
Principal Investigator: POLACK BENOIT, PHD         
C.H. de La Rochelle Not yet recruiting
La Rochelle, France, 17019
Contact: VANDAMME XAVIER, MD       xavier.vandamme@ch-larochelle.fr   
Principal Investigator: VANDAMME XAVIER, MD         
Principal Investigator: BREHANT CATHERINE, MD         
C.H. de Versailles Recruiting
Le Chesnay, France, 78150
Contact: PICO FERNANDO, PHD       fpico@ch-versailles.fr   
Principal Investigator: PICO FERNANDO, PHD         
Principal Investigator: MARTIN BASTENAIRE BRIGITTE, MD         
Hôpital J. Monod Not yet recruiting
Le Havre, France, 76083
Contact: VASCHALDE YVAN, MD       yvaschalde@ch-havre.fr   
Principal Investigator: VASCHALDE YVAN, MD         
Principal Investigator: SALADIN THIRON CATHERINE, MD         
C.H.U. Limoges Recruiting
Limoges, France, 87042
Contact: MACIAN MONTORO FRANSCICO, MD       francisco.macian-montoro@chu-limoges.fr   
Principal Investigator: MACIAN MONTORO FRANSCICO, MD         
Principal Investigator: DONNARD MAGALI, MD         
C.H. François Quesnay Not yet recruiting
Mantes La Jolie, France, 78201
Contact: ILLE OLIVIER, MD       o.ille@ch-mantes.fr   
Principal Investigator: ILLE OLIVIER, MD         
Principal Investigator: BIGEL MARIE LAURE, MD         
Hôpital de la Timone Recruiting
Marseille, France, 13385
Contact: MILANDRE LOIC, MD       lmilandre@ap-hm.fr   
Principal Investigator: MILANDRE LOIC, MD         
Principal Investigator: MORANGE PIERRE EMMANUEL, PHD         
C.H. de Meaux Recruiting
Meaux, France, 77108
Contact: KERNEIS ANDRE, MD       e-andre-kerneis@ch-meaux.fr   
Principal Investigator: KERNEIS ANDRE, MD         
Principal Investigator: KLAPCZYNSKI FREDERIC, MD         
Hôpital Guy de Chauliac Not yet recruiting
Montpellier, France, 34295
Contact: ARQUIZAN CAROLINE, MD       c-arquizan@chu-montpellier.fr   
Principal Investigator: ARQUIZAN CAROLINE, MD         
Principal Investigator: BIRON ANDREANI CHRISTINE, MD         
Hôpital Nord de Laënnec Recruiting
Nantes, France, 44093
Contact: GUILLON BENOIT, MD       benoit.guillon@chu-nantes.fr   
Principal Investigator: GUILLON BENOIT, MD         
Principal Investigator: TERNISIEN CATHERINE, MD         
G.H.U. Carémeau Not yet recruiting
Nimes, France, 30029
Contact: BOULY STEPHANE, MD       stephane.bouly@chu-nimes.fr   
Principal Investigator: BOULY STEPHANE, MD         
Principal Investigator: GRIS JEAN CHRISTOPHE, PHD         
Principal Investigator: COCHERY NOUVELLON EVA, MD         
GH Pitié-Salpêtrière Not yet recruiting
Paris, France, 75651
Contact: SAMSON YVES, PHD       yves.samson@psl.aphp.fr   
Principal Investigator: SAMSON YVES, PHD         
Principal Investigator: MARTIN TOUTAIN ISABELLE, MD         
G.H. Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: ZUBER MATHIEU, PHD       mzuber@hpsj.fr   
Principal Investigator: ZUBER MATHIEU, PHD         
Principal Investigator: LAPLANCHE SOPHIE, MD         
C.H. de Perpignan - Hôpital Saint-Jean Recruiting
Perpignan, France, 66046
Contact: SABLOT DENIS, MD       denis.sablot@ch-perpignan.fr   
Principal Investigator: SABLOT DENIS, MD         
Principal Investigator: GUEUDET PHILIPPE, MD         
CHI de Poissy- site de Poissy Recruiting
Poissy, France, 78300
Contact: TASSAN PHILIPPE, MD       ptassan@chi-poissy-st-germain.fr   
Principal Investigator: PELTIER YVES, MD         
Principal Investigator: TASSAN PHILIPPE, MD         
C.H.U de Poitiers Recruiting
Poitiers, France, 86021
Contact: GODENECHE GAELLE, MD       g.godeneche@chu-poitiers.fr   
Principal Investigator: GODENECHE GAELLE, MD         
Principal Investigator: BOINOT CATHERINE, MD         
CHU hopitaux de rouen Recruiting
Rouen, France, 76000
Contact: LE CAM DUCHEZ VERONIQUE, MD    0232881397    veronique.le-cam-duchez@chu-rouen.fr   
Principal Investigator: LE CAM DUCHEZ VERONIQUE, MD         
Sub-Investigator: TRIQUENOT BAGAN AUDE, MD         
Principal Investigator: BORG JEANNE YVONNE, MD         
C.H. Yves Le Foll Not yet recruiting
Saint Brieuc, France, 22027
Contact: GOLFIER VERONIQUE, MD       veronique.golfier@ch-stbrieuc.fr   
Principal Investigator: GOLFIER VERONIQUE, MD         
Principal Investigator: VADUVA CLAUDIA, MD         
Principal Investigator: LELOUP POILANE BEATRICE, MD         
C.H. Saint-Denis Not yet recruiting
Saint Denis, France, 33205
Contact: DEBROUCKER THOMAS, MD       thomas.debroucker@ch-stdenis.fr   
Principal Investigator: DEBROUCKER THOMAS, MD         
Principal Investigator: PORTE ANNIE, MD         
C.H.U de Strasbourg Not yet recruiting
Strasbourg, France, 67098
Contact: WOLFF VALERIE, MD       valerie.wolff@chru-strasbourg.fr   
Principal Investigator: WOLFF VALERIE, MD         
Principal Investigator: GRUNEBAUM LELIA, MD         
Principal Investigator: DESPREZ DOMINIQUE, MD         
CHRU Bretonneau Not yet recruiting
Tours, France, 37000
Contact: BONNAUD ISABELLE, MD       bonnaud@med.univ-tours.fr   
Principal Investigator: BONNAUD ISABELLE, MD         
Principal Investigator: GRUEL YVES, PHD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Study Director: LE CAM DUCHEZ VERONIQUE, MD CHU HOPITAUX DE ROUEN
  More Information

No publications provided

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: June 18, 2014
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:
Venous Thrombosis
Venous Thromboembolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Thrombin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014