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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03268668
Acronym
COMPO-CLOT
Enrollment
1200
Registered
2017-08-31
Start date
2017-07-13
Completion date
2028-01-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biological Specimen Banks, Biomarkers, Etiology, Prognosis, Stroke, Acute

Brief summary

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.

Interventions

OTHERCollection 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

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).3 monthsSince 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).

Countries

France

Contacts

CONTACTAmélie Yavchitz, MD PhD
ayavchitz@for.paris0148036454
CONTACTJean-Philippe Désilles, MD
jpdesilles@for.paris0672872906
PRINCIPAL_INVESTIGATORJean-Philippe Désilles, MD

Fondation Ophtalmologique A. de Rothschild

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026