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

May 13, 2026 updated by: University Hospital, Rouen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients over 16 years old hospitalized with an acute cerebral venous thrombosis

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cerebral Venous Thrombosis
Diagnostic test: Blood samples

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)

Other: Neuroimaging
Imaging performed at baseline and at month 3 (except in case of pregnancy or contraindications) to evaluate cerebral venous thrombosis and parenchymal sequelae.
Other: Clinical assessments
Standardized neurological and functional evaluations are performed, including NIHSS, Rankin, Glasgow, and Barthel scores at predefined time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of thrombin generation parameters
Time Frame: 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)
one year
Evolution of D Dimers concentration
Time Frame: 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)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of thrombin generation parameters after end of treatment
Time Frame: 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)
one year
MR Imaging and Thrombin generation parameters
Time Frame: one year
Number of venous occlusions on MR Imaging and correlation with thrombin generation parameters
one year
MR Imaging and D Dimers concentration
Time Frame: one year
Number of venous occlusions on MR Imaging and correlation with D Dimers concentration
one year
Evolution of D Dimers concentration after treatment
Time Frame: 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)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Study Director: LE CAM DUCHEZ VERONIQUE, MD, CHU hopitaux de rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimated)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/087/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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