Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

Recruiting

• Conditions: Cerebral Hypoxia; Ischemic Stroke
• Interventions: Other: Blood sampling

• Registration Number: NCT04971564
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-21
• Study Start: 2024-03-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-06-22
• Study Completion: 2026-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Secondary exclusion criteria :

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Blood sampling	Patients without cerebral hypoxia
Case	Blood sampling	Patients with cerebral hypoxia victims of ischaemic stroke, acute parenchymal haemorrhage or subarachnoid haemorrhage

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, Ile-de-France, France