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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 15, 2023

Interventions

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

Arms, Groups and Cohorts

  • Case
    • Patients with cerebral hypoxia victims of ischaemic stroke, acute parenchymal haemorrhage or subarachnoid haemorrhage
  • Control
    • Patients without cerebral hypoxia

Clinical Trial Outcome Measures

Primary Measures

  • Biomarker rates at day 0
    • Time Frame: 24 hours
    • Biomarker: Neutro-Plaket aggregates, extra-cellular DNA networks, von Willebrand Factor

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondation Ophtalmologique Adolphe de Rothschild
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • François DELVOYE, 0148036556, fdelvoye@for.paris

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