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Recruiting Not applicable NCT04621357

Influence of Cerebral Oedema in Intracerebral Haemorrhage

No applicable phase (e.g. observational)
Conditions: Stroke Intra Cerebral Hemorrhage

Sponsor: University Hospital, Lille

trial.available_in: БГ
Overview
In 2020, IntraCerebral Haemorraghe (ICH) remains the most devastating type of stroke. Besides stroke unit care, no specific treatment has been proven effective yet. Perihaematomal oedema (PHO) could be a promising therapeutic target. However, the mechanisms, the natural history as well as the clinical impact of this PHO remain unclear. The COPITCH study has been designed to answer these questions
Who can participate
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
Interventions
Brain MRI
RADIATION
Biological biomarkers
BIOLOGICAL
Locations 1
France (1)
CHU de Lille
Lille
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.06.2021
Completion date
03.12.2027
Registry ID
NCT04621357
Source
clinicaltrials.gov
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