← Back to Clinical Trials
Recruiting NCT04621357

Influence of Cerebral Oedema in Intracerebral Haemorrhage

Trial Parameters

Condition Stroke
Sponsor University Hospital, Lille
Study Type INTERVENTIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-06-04
Completion 2025-06
Interventions
Brain MRIBiological biomarkers

Brief Summary

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

Eligibility 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

Related Trials