Cerebral Venous ThrombosisPHRC-TVCNCT02013635
Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Clinical and Radiological Correlations
A study testing Blood samples, Neuroimaging and Clinical assessments in people with Cerebral Venous Thrombosis, run by University Hospital, Rouen at 36 sites in France.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- Blood samples, Neuroimaging and Clinical assessments
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 36 sitesFrance
- Study dates
- Jul 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 16 years old hospitalized with an acute cerebral venous thrombosis, confirmed by by cerebral imaging
Who cannot join
None listed.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
France36 sites
Chu Amiens
Amiens, 80054
Chu D' Angers
Angers, 49933
Ch Victor Dupouy
Argenteuil, 95107
CH Côte Basque
Bayonne, 64100
Hôpital Jean Minjioz
Besançon, 25030
Hôpital Pellegrin - CHU Bordeaux
Bordeaux, 33076
Hôpital de la Cavale Blanche
Brest, 29609
Hôpital Neurologique de Lyon
Bron, 69677
Hôpital Côte de Nacre
Caen, 14033
CHU Estaing
Clermont-Ferrand, 63003
Hôpitaux Civils de Colmar
Colmar, 68024
C.H. de Compiègne
Compiègne, 60321
Hôpital Henri Mondor
Créteil, 94010
CHU-Hôpital Général
Dijon, 21033
C.H.I. Eure-Seine
Évreux, 27000
C.H.U. de Grenoble
Grenoble, 38043
C.H. de La Rochelle
La Rochelle, 17019
C.H. de Versailles
Le Chesnay, 78150
Hôpital J. Monod
Le Havre, 76083
C.H.U. Limoges
Limoges, 87042
C.H. François Quesnay
Mantes-la-Jolie, 78201
Hôpital de la Timone
Marseille, 13385
C.H. de Meaux
Meaux, 77108
Hôpital Guy de Chauliac
Montpellier, 34295
Hôpital Nord de Laënnec
Nantes, 44093
G.H.U. Carémeau
Nîmes, 30029
G.H. Paris Saint-Joseph
Paris, 75014
GH Pitié-Salpêtrière
Paris, 75651
C.H. de Perpignan - Hôpital Saint-Jean
Perpignan, 66046
CHI de Poissy- site de Poissy
Poissy, 78300
C.H.U de Poitiers
Poitiers, 86021
CHU hopitaux de rouen
Rouen, 76000
C.H. Yves Le Foll
Saint-Brieuc, 22027
C.H. Saint-Denis
Saint-Denis, 33205
C.H.U de Strasbourg
Strasbourg, 67098
CHRU Bretonneau
Tours, 37000
About this study
Official title: 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.
Read more
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.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- Blood samples, Neuroimaging, Clinical assessments
- Keywords
- cerebral venous thrombosis, thrombin generation, d-dimers, clinical evolution
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
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)
NeuroimagingOther
Imaging performed at baseline and at month 3 (except in case of pregnancy or contraindications) to evaluate cerebral venous thrombosis and parenchymal sequelae.
Clinical assessmentsOther
Standardized neurological and functional evaluations are performed, including NIHSS, Rankin, Glasgow, and Barthel scores at predefined time points.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Venous Thrombosis | Experimental | Not described Receives: Diagnostic Test: Blood samples; Other: Neuroimaging; Other: Clinical assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: one year
Secondary outcomes (4)
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)
Measured: one year
MR Imaging and Thrombin generation parameters
Number of venous occlusions on MR Imaging and correlation with thrombin generation parameters
Measured: one year
MR Imaging and D Dimers concentration
Number of venous occlusions on MR Imaging and correlation with D Dimers concentration
Measured: one year
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJul 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LE CAM DUCHEZ VERONIQUE, MD, Study director, CHU HOPITAUX DE ROUEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013635
- Sponsor's protocol ID
- 2010/087/HP
- Acronym
- PHRC-TVC
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2011
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34819911
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Correlation With Clinical and Radiological Evolution
- ClinicalTrials.gov ID
- NCT02013635
- Acronym / sponsor ID
- PHRC-TVC / 2010/087/HP
- Conditions
- Cerebral Venous Thrombosis
- Keywords
- cerebral venous thrombosis, thrombin generation, d-dimers, clinical evolution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Venous Thrombosis | Experimental | Diagnostic Test: Blood samples, Other: Neuroimaging, Other: Clinical assessments |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 16 years old hospitalized with an acute cerebral venous thrombosis, confirmed by by cerebral imaging
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood 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) | Diagnostic test | Cerebral Venous Thrombosis |
| NeuroimagingImaging performed at baseline and at month 3 (except in case of pregnancy or contraindications) to evaluate cerebral venous thrombosis and parenchymal sequelae. | Other | Cerebral Venous Thrombosis |
| Clinical assessmentsStandardized neurological and functional evaluations are performed, including NIHSS, Rankin, Glasgow, and Barthel scores at predefined time points. | Other | Cerebral Venous Thrombosis |
Primary outcome
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)
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)
4 secondary outcomes
Evolution of thrombin generation parameters after end of treatment
Time frame: one year
MR Imaging and Thrombin generation parameters
Time frame: one year
MR Imaging and D Dimers concentration
Time frame: one year
Evolution of D Dimers concentration after treatment
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 34819911Triquenot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LE CAM DUCHEZ VERONIQUE, MD study director
CHU HOPITAUX DE ROUEN
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples, Neuroimaging and Clinical assessments in people with Cerebral Venous Thrombosis, run by University Hospital, Rouen at 36 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of thrombin generation parameters (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.