Cerebral HypoxiaRADICALNCT04971564
Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia
An observational study of Cerebral Hypoxia and Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hypoxia, Ischemic Stroke
- What is being tested?
- Blood sampling
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 22 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at the Rothschild Foundation Hospital within the first 24 hours of an acute neurological symptomatology
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75010
Amélie Yavchitz, MD, 01 48 03 64 54, ayavchitz@for.paris
About this study
Official title: Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia. A Case-control Trial Nested in a Cohort
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
- Being tested
- Blood sampling
- Medical subject headings
- Hypoxia, Brain, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling will be made to Day 0, Day 3 and to 3 month after inclusion
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with cerebral hypoxia victims of ischaemic stroke, acute parenchymal haemorrhage or subarachnoid haemorrhage Receives: Other: Blood sampling | |
| Control | Patients without cerebral hypoxia Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker rates at day 0
Biomarker: Neutro-Plaket aggregates, extra-cellular DNA networks, von Willebrand Factor
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start19 Mar 2024
- Primary completion22 Jun 2026 (estimated)
- Study completion22 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HypoxiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971564
- Sponsor's protocol ID
- FDE_2021_19
- Acronym
- RADICAL
- Status last verified
- Jan 2026
- First submitted
- 12 Jul 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia. A Case-control Trial Nested in a Cohort
- ClinicalTrials.gov ID
- NCT04971564
- Acronym / sponsor ID
- RADICAL / FDE_2021_19
- Conditions
- Cerebral Hypoxia, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 22 Jun 2026 (estimated)
- Study completion
- 22 Jun 2026 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Blood samplingPatients with cerebral hypoxia victims of ischaemic stroke, acute parenchymal haemorrhage or subarachnoid haemorrhage |
| Control | – | Other: Blood samplingPatients without cerebral hypoxia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the Rothschild Foundation Hospital within the first 24 hours of an acute neurological symptomatology
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling will be made to Day 0, Day 3 and to 3 month after inclusion | Other | Case, Control |
Primary outcome
Biomarker rates at day 0
Time frame: 24 hours
Biomarker: Neutro-Plaket aggregates, extra-cellular DNA networks, von Willebrand Factor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Related trials for Cerebral Hypoxia
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hypoxia and Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François DELVOYE (0148036556, fdelvoye@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker rates at day 0 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.