Understanding the impact of brain swelling in stroke patients
Official title: Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
Run by University Hospital, Lille · NCT04621357 · Data updated 2026-11-12
This study is trying to understand how brain swelling affects people who have had a severe type of stroke to see if it can help improve their treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | June 4, 2021 |
| Main results expected | December 3, 2027 |
| Study ends | December 3, 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT04621357 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with spontaneous intracerebral hemorrhage admitted within 12 hours of stroke onset.
✕Probably not a fit
Patients with secondary intracerebral hemorrhages or those with significant comorbidities affecting life expectancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the role of perihaematomal oedema (PHO) in patients with spontaneous intracerebral hemorrhage (ICH), a severe type of stroke. It aims to clarify the mechanisms and clinical significance of PHO by utilizing brain MRI and analyzing biological biomarkers. Patients will be enrolled within 12 hours of stroke onset to assess the natural history and potential therapeutic targets related to PHO. The findings could provide insights into improving treatment strategies for ICH.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic approaches for managing intracerebral hemorrhage and improving patient outcomes.
How similar studies have gone: While the specific focus on perihaematomal oedema in ICH is relatively novel, similar studies have explored brain swelling in stroke with varying degrees of success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * With a spontaneous ICH, i.e. non traumatic * Admitted within 12 hours of stroke onset. For wake-up strokes, time of last seen well will be considered as stroke onset * Patient insured under the French social security * Consent form signed Exclusion Criteria: * Pure intraventricular haemorrhages * "secondary" ICH: ICH resulting from intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour; haemorrhagic transformation within an infarct * Pre-admission modified Rankin score of 4 or 5 * Life expectancy of less than 1 year related to comorbidities (end stage cancer, end stage organ failure) * Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done) * Adults who are deprived of their liberty by judicial or administrative decision * Referral from other hospitals * Contra-indication to MRI : claustrophobia, ocular metallic foreign bodies (accidental or other) or in a risk area (nervous or vascular system);irremovable implanted medical device (pacemaker, neurostimulator, cochlear implants and others);metallic heart valve (mainly old heart valves) or vascular clips previously implanted on cranial aneurysms; gadolinium allergy * No consent form
Where it's running
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CHU de Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Charlotte Cordonnier, MD,PhD — University Hospital, Lille
- Study coordinator: Charlotte Cordonnier, MD,PhD
- Email: charlotte.cordonnier@chu-lille.fr
- Phone: 0320445962
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
-
Minimally invasive treatment for brain hemorrhage compared to standard care
This study is testing a new, less invasive treatment for brain bleeding to see if it works better than standard care for patients who arrive at the emergency room with a significant hemorrhage.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.