Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis

NCT ID: NCT03268668

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-13

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Acute Biological Specimen Banks Biomarkers Etiology Prognosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Collection of thrombus that is responsible for stroke and blood sample

A blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria :

A) TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase \> 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe Désilles, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHU Caen

Caen, , France

Site Status RECRUITING

Chu Limoges

Limoges, , France

Site Status RECRUITING

CHRU de Nancy

Nancy, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

Hôpital Lariboisière AP-HP

Paris, , France

Site Status RECRUITING

Centre hospitalier Sainte-Anne

Paris, , France

Site Status RECRUITING

Fondation Ophtalmologique A. de Rothschild

Paris, , France

Site Status RECRUITING

CHU de Rennes

Rennes, , France

Site Status COMPLETED

Hôpital Foch

Suresnes, , France

Site Status RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, , France

Site Status RECRUITING

CHRU Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Amélie Yavchitz, MD PhD

Role: CONTACT

0148036454 ext. +33

Jean-Philippe Désilles, MD

Role: CONTACT

0672872906

Facility Contacts

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Gaultier MARNAT, MD

Role: primary

05 56 79 56 79 ext. + 33

Charlotte Barbier, MD

Role: primary

02 31 06 46 91 ext. + 33

Aymeric ROUCHAUD, Pr

Role: primary

05 55 05 80 11 ext. + 33

Benjamin GORY, Pr

Role: primary

03 83 85 95 27 ext. + 33

Romain BOURCIER, MD

Role: primary

02 40 16 56 08 ext. +33

Alexis GUEDON, MD

Role: primary

01 49 95 81 17 ext. + 33

Olivier NAGGARA, MD

Role: primary

01 45 65 80 00 ext. + 33

Jean-Philippe DESILLES, Pr

Role: primary

01 48 03 69 13 ext. +33

Arthur CONSOLI, MD

Role: primary

01 46 25 20 00 ext. +33

Quentin HOLAY, MD

Role: primary

04 83 16 21 95 ext. + 33

Héloïse IFERGAN, MD

Role: primary

02 47 47 47 47 ext. + 33

References

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Di Meglio L, Desilles JP, Solonomenjanahary M, Labreuche J, Ollivier V, Dupont S, Deschildre C, Maacha MB, Consoli A, Lapergue B, Piotin M, Blanc R, Ho-Tin-Noe B, Mazighi M; compoCLOT study groupdagger. DNA Content in Ischemic Stroke Thrombi Can Help Identify Cardioembolic Strokes Among Strokes of Undetermined Cause. Stroke. 2020 Sep;51(9):2810-2816. doi: 10.1161/STROKEAHA.120.029134. Epub 2020 Aug 19.

Reference Type DERIVED
PMID: 32811390 (View on PubMed)

Other Identifiers

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JDS_2017_8

Identifier Type: -

Identifier Source: org_study_id

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