Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia
RADICAL
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2021
CompletedFirst Posted
Study publicly available on registry
July 21, 2021
CompletedStudy Start
First participant enrolled
March 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 22, 2026
January 22, 2026
January 1, 2026
2.3 years
July 12, 2021
January 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarker rates at day 0
Biomarker: Neutro-Plaket aggregates, extra-cellular DNA networks, von Willebrand Factor
24 hours
Study Arms (2)
Case
Patients with cerebral hypoxia victims of ischaemic stroke, acute parenchymal haemorrhage or subarachnoid haemorrhage
Control
Patients without cerebral hypoxia
Interventions
Blood sampling will be made to Day 0, Day 3 and to 3 month after inclusion
Eligibility Criteria
Patients treated at the Rothschild Foundation Hospital within the first 24 hours of an acute neurological symptomatology
You may qualify if:
- \- For cases, admitted within the first 36 hours of an acute neurological symptom related to :
- An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure,
- A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4,
- An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission \>4.
- For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score.
- Express consent to participate in the study.
- Member or beneficiary of a social security.
You may not qualify if:
- Pre-existing functional and/or cognitive disability
- Patient under legal protection.
- Pregnant or breastfeeding woman.
- Patient with secondary haemorrhagic transformation.
- Patients with an ischaemic lesion visible on imaging, unrelated to large vessel occlusion and therefore ineligible for mechanical thrombectomy.
- Patients diagnosed with an acute non-vascular neurological pathology (migraine, epilepsy, etc.).
- TIA patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging.
- Excluded patients will be replaced.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75010, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2021
First Posted
July 21, 2021
Study Start
March 19, 2024
Primary Completion (Estimated)
June 22, 2026
Study Completion (Estimated)
June 22, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01