Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

NCT ID: NCT04971564

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2026-06-22

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.

Conditions

Cerebral Hypoxia; Ischemic Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case

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

Blood sampling

Intervention Type: OTHER

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

Control

Patients without cerebral hypoxia

Blood sampling

Intervention Type: OTHER

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

Interventions

Blood sampling

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

OR

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Fondation Adolphe de Rothschild

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

François DELVOYE

Role: CONTACT

fdelvoye@for.paris

0148036556

Amélie Yavchitz

Role: CONTACT

fyavchitz@for.paris

0148036556

Facility Contacts

Amélie Yavchitz, MD

Role: primary

ayavchitz@for.paris

01 48 03 64 54

Other Identifiers

FDE_2021_19

Identifier Type: -

Identifier Source: org_study_id