ClinicalTrials.gg
RecruitingNCT04971564RADICALUpdated Nov 9, 2026

Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia

An observational study in Cerebral Hypoxia and Ischemic Stroke, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Updated Nov 9, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Hypoxia
  • Ischemic Stroke
03

In context

Hypoxia, Brain

81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 25 observational studies indexed under Hypoxia, Brain.

Browse Hypoxia, Brain studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients treated at the Rothschild Foundation Hospital within the first 24 hours of an acute neurological symptomatology

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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.).
  • patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging.

Excluded patients will be replaced.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Case

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

    Other: Blood sampling

  • Control

    Patients without cerebral hypoxia

    Other: Blood sampling

Interventions

  • OtherBlood sampling

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

06

What researchers measure

Primary outcomes

  1. Biomarker rates at day 0

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

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Mar 2024 (actual). Primary completion is estimated for Jun 2028, 50 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Jun 2026 → Jun 2028 and completion Jun 2026 → Sep 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2021
First posted
Jul 21, 2021
StartActual
Mar 19, 2024
Primary completionEst.
Jun 18, 2028was Jun 2026
CompletionEst.
Sep 18, 2028was Jun 2026
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jun 22, 2026→Jun 18, 2028
Nov 9, 2026
Study completion
Jun 22, 2026→Sep 18, 2028
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Primary completion Jun 22, 2026→Jun 18, 2028
    Study completion Jun 22, 2026→Sep 18, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04971564
Responsible party
Sponsor
First posted
Jul 21, 2021
Start date
Mar 19, 2024
Primary completion
Jun 18, 2028 (estimated)
Completion
Sep 18, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

François DELVOYE
Contact
fdelvoye@for.paris
0148036556
Amélie Yavchitz
Contact
fyavchitz@for.paris
0148036556

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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