RADICAL: Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04971564

Collaborator

(none)

200

Enrollment

28.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Hypoxia Ischemic Stroke	Other: Blood sampling

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Oct 15, 2024

Anticipated Study Completion Date :

Feb 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Case Patients with cerebral hypoxia victims of ischaemic stroke, acute parenchymal haemorrhage or subarachnoid haemorrhage	Other: Blood sampling Blood sampling will be made to Day 0, Day 3 and to 3 month after inclusion
Control Patients without cerebral hypoxia	Other: Blood sampling Blood sampling will be made to Day 0, Day 3 and to 3 month after inclusion

Arm

Intervention/Treatment

Case

Patients with cerebral hypoxia victims of ischaemic stroke, acute parenchymal haemorrhage or subarachnoid haemorrhage

Other: Blood sampling

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

Control

Patients without cerebral hypoxia

Other: Blood sampling

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04971564

Other Study ID Numbers:

FDE_2021_19

First Posted:

Jul 21, 2021

Last Update Posted:

Jun 9, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022