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Clinical Trials/NCT03268668
NCT03268668RecruitingNot Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild9 sites in 1 country1,200 target enrollmentStarted: July 13, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,200
Locations
9
Primary Endpoint
Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (9)

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