RecruitingNot ApplicableNCT04621357

Influence of Cerebral Oedema in Intracerebral Haemorrhage

Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage

Sponsor

University Hospital, Lille

Enrollment

500 participants

Start Date

Jun 4, 2021

Study Type

INTERVENTIONAL

Conditions

Stroke Intra Cerebral Hemorrhage

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria9

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