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

Recruiting

• Conditions: Prognosis; Stroke, Acute; Etiology; Biological Specimen Banks; Biomarkers

• Registration Number: NCT03268668
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Patient aged 18 years and older; having a cerebral infarction following arterial occlusion; treated by thrombectomy; patient in whom a thrombus could be collected.

Exclusion Criteria

• Patient benefiting from a legal protection measure; pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).	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).

Trial Locations

Locations (9)

CHU de Nantes; 🇫🇷 Nantes, France

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France

CHRU de Nancy; 🇫🇷 Nancy, France

Chu Limoges; 🇫🇷 Limoges, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU Caen; 🇫🇷 Caen, France

CHU de Rennes; 🇫🇷 Rennes, France

Hôpital Foch,; 🇫🇷 Suresnes, France

Hôpital d'Instruction des Armées Sainte-Anne; 🇫🇷 Toulon, France