Understanding the impact of brain swelling in stroke patients
Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04621357 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with spontaneous intracerebral hemorrhage admitted within 12 hours of stroke onset.
Not a fit: Patients with secondary intracerebral hemorrhages or those with significant comorbidities affecting life expectancy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.