Examining biomarkers in patients with acute cerebral hypoxia

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

This study is testing the levels of certain inflammation markers in patients with acute brain oxygen loss from conditions like stroke and bleeding in the brain to see how they compare to those without these issues.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Research network)
• Locations: 1 site (Paris, Île-de-France Region)
• Trial ID: NCT04971564 on ClinicalTrials.gov

What this trial studies

This observational trial aims to investigate the levels of thrombo-inflammation biomarkers in patients experiencing acute cerebral hypoxia due to specific conditions such as ischemic stroke, subarachnoid hemorrhage, and intra-parenchymal hematoma. It compares these biomarker concentrations to those in a control group of patients without cerebral hypoxia. Additionally, the study will explore the relationship between biomarker levels and clinical outcomes in patients with cerebral hypoxia. Blood samples will be collected for analysis.

Who should consider this trial

Good fit: Ideal candidates include patients admitted within 36 hours of acute neurological symptoms related to ischemic stroke, subarachnoid hemorrhage, or intra-parenchymal hematoma.

Not a fit: Patients with pre-existing disabilities, those under legal protection, pregnant or breastfeeding women, and individuals with secondary hemorrhagic transformation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of thrombo-inflammation in cerebral hypoxia, potentially leading to improved diagnostic and therapeutic strategies.

How similar studies have performed: While this approach is focused on specific biomarkers in acute cerebral hypoxia, similar studies have shown promise in understanding thrombo-inflammation in other neurological conditions.

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.

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.

Where this trial is running

Paris, Île-de-France Region

• Hôpital Fondation Adolphe de Rothschild — Paris, Île-de-France Region, France (Recruiting)

Study contacts

• Study coordinator: François DELVOYE

Conditions Cerebral Hypoxia; Ischemic Stroke