Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Stroke trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorUniversity Hospital, Lille
Academic / other
Locations1 site (Lille)
StatusRecruiting
StartedJune 4, 2021
Main results expectedDecember 3, 2027
Study endsDecember 3, 2027
Registry record updatedApril 22, 2026
Trial IDNCT04621357 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

  • CHU de Lille
    Lille, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.