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NCT Number: NCT04971564

Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Fondation Adolphe de Rothschild

Paris, Île-de-France Region, 75010, France

Location status: Recruiting

Location contact

Amélie Yavchitz, MD

CONTACT

[email protected]

01 48 03 64 54

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

  1. Biomarker rates at day 0

    Time frame: 24 hours

    Biomarker: Neutro-Plaket aggregates, extra-cellular DNA networks, von Willebrand Factor

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie Yavchitz

CONTACT

[email protected]

0148036556

François DELVOYE

CONTACT

[email protected]

0148036556

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: RADICAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2021
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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