- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03268668
Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis (COMPO-CLOT)
The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology.
The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amélie Yavchitz, MD PhD
- Phone Number: +33 0148036454
- Email: ayavchitz@for.paris
Study Contact Backup
- Name: Jean-Philippe Désilles, MD
- Phone Number: 0672872906
- Email: jpdesilles@for.paris
Study Locations
-
-
-
Bordeaux, France, 33000
- Recruiting
- CHU de Bordeaux
-
Contact:
- Gaultier MARNAT, MD
- Phone Number: + 33 05 56 79 56 79
- Email: gaultier.marnat@chu-bordeaux.fr
-
Caen, France, 14000
- Recruiting
- CHU caen
-
Contact:
- Charlotte Barbier, MD
- Phone Number: + 33 02 31 06 46 91
- Email: barbier-ch@chu-caen.fr
-
Limoges, France, 87000
- Recruiting
- CHU Limoges
-
Contact:
- Aymeric ROUCHAUD, Pr
- Phone Number: + 33 05 55 05 80 11
- Email: AYMERIC.ROUCHAUD2@chu-limoges.fr
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Nancy, France, 54000
- Recruiting
- CHRU de NANCY
-
Contact:
- Benjamin GORY, Pr
- Phone Number: + 33 03 83 85 95 27
- Email: b.gory@chru-nancy.fr
-
Nantes, France, 44093
- Recruiting
- Chu de Nantes
-
Contact:
- Romain BOURCIER, MD
- Phone Number: +33 02 40 16 56 08
- Email: Romain.BOURCIER@chu-nantes.fr
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Paris, France, 75019
- Recruiting
- Fondation Ophtalmologique A. De Rothschild
-
Contact:
- Jean-Philippe DESILLES, Pr
- Phone Number: +33 01 48 03 69 13
- Email: jpdesilles@for.paris
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Paris, France, 75014
- Recruiting
- Centre Hospitalier Sainte-Anne
-
Contact:
- Olivier NAGGARA, MD
- Phone Number: + 33 01 45 65 80 00
- Email: o.naggara@ghu-paris.fr
-
Paris, France, 75010
- Recruiting
- Hôpital Lariboisière AP-HP
-
Contact:
- Alexis GUEDON, MD
- Phone Number: + 33 01 49 95 81 17
- Email: alexis.guedon@aphp.fr
-
Rennes, France, 35000
- Completed
- CHU de Rennes
-
Suresnes, France, 92150
- Recruiting
- Hopital Foch
-
Contact:
- Arthur CONSOLI, MD
- Phone Number: +33 01 46 25 20 00
- Email: a.consoli@hopital-foch.com
-
Toulon, France, 83000
- Recruiting
- Hôpital d'instruction des armées Sainte-Anne
-
Contact:
- Quentin HOLAY, MD
- Phone Number: + 33 04 83 16 21 95
- Email: quentin.holay@intradel.gouv.fr
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Tours, France, 37000
- Recruiting
- CHRU Tours
-
Contact:
- Héloïse IFERGAN, MD
- Phone Number: + 33 02 47 47 47 47
- Email: h.ifergan@chu-tours.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years and older
- Presenting with cerebral infarction following arterial occlusion
- Treated for mechanical thrombectomy (whether performed or not)
- Free, informed, and express consent of the patient or their relatives (emergency inclusion procedure)
- For retrospective patients: thrombus already collected (according to the center's usual practice or for another research project).
Exclusion Criteria:
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).
Time Frame: 3 months
|
Since this is an observational, exploratory study that correlates laboratory data (eg for thrombus: fibrinolytic, pro-oxidant activity, eg for blood: plasma fibrinolysis markers, presence of factor Von Willebrand, etc.) and clinical data (characteristics of the stroke, including the TOAST etiological score, the TICI score (TICI = thrombolysis in cerebral infarction), the NIHSS score, etc.), there is no single primary endpoint. Clinical data will be collected up to 3 months after stroke (Rankin score). |
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Philippe Désilles, MD, Fondation Ophtalmologique A. De Rothschild
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Stroke
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- JDS_2017_8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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