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NCT04971564 Clinical Trial

Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

Ischemic Stroke Clinical Trial

— RADICAL  

Official title:
Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia. A Case-control Trial Nested in a Cohort

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04971564
Other study ID # FDE_2021_19
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 15, 2024
Est. completion date August 15, 2025

Study information
Verified date February 2024
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact François DELVOYE
Phone 0148036556
Email fdelvoye@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date August 15, 2025
Est. primary completion date August 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Admitted to the Rothschild Foundation within the first 24 hours of an acute neurological symptomatology related to : - ischemic stroke eligible for a mechanical thrombectomy procedure - subarachnoid haemorrhage due to aneurysmal rupture: patient with at least a modified Fisher scale 3 or 4 (Appendix 4) and a World Federation of Neurological Surgeons (WFNS) score of 2 or more - intra-parenchymal haematoma with a Glasgow Coma Scale (GCS) strictly below 15. - tissue-based transient ischaemic attack - no lesion found on imaging - with ABCD2= 2 (control group). - Hospitalisation to the Fondation Adolphe de Rothschild Hospital at least 72 hours is planned Exclusion Criteria: - Pre-existing functional and/or cognitive disability - Patient under legal protection - Pregnant or breastfeeding woman

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sampling
Blood sampling will be made to Day 0, Day 3 and to 3 month after inclusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome
Type Measure Description Time frame Safety issue
Primary Biomarker rates at day 0 Biomarker: Neutro-Plaket aggregates, extra-cellular DNA networks, von Willebrand Factor 24 hours
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