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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT03268668
Collaborator
(none)
1,200
7
59.6
171.4
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Collection of thrombus that is responsible for stroke and blood sample

Study Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis
Actual Study Start Date :
Jul 13, 2017
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux Bordeaux France 33000
2 CHU Caen Caen France
3 CHRU de Nancy Nancy France 54000
4 CHU de Nantes Nantes France 44 093
5 Fondation Ophtalmologique A. de Rothschild Paris France 75019
6 CHU de Rennes Rennes France 35000
7 Hôpital Foch, Suresnes France 92 150

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Jean-Philippe Désilles, MD, Fondation Ophtalmologique A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT03268668
Other Study ID Numbers:
  • JDS_2017_8
First Posted:
Aug 31, 2017
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022