Influence of Cerebral Oedema in Intracerebral Haemorrhage

Study Overview
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Brief Summary
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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

Official Title
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Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage

Conditions
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Stroke, Intra Cerebral Hemorrhage

Intervention / Treatment
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* Radiation: Brain MRI
* Biological: Biological biomarkers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with intracerebral haemorrhage<br>Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma. | Radiation: Brain MRI<br>* Brain MRI will include differents sequences.<br>Biological: Biological biomarkers<br>* Biological biomarkers will include a set of systemic inflammatory markers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor functional outcome defined as a modified Rankin Scale of 4 or more |  | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall distribution of the modified Rankin scale at 3- and 12 months | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. | at 3 months and 12 months | 
| Early neurological deterioration defined as more than 4 points on the NIHSS score | The NIHSS score (NIH Stroke Scale) is used to monitor the progression of an ischemic or hemorrhagic stroke. It is rated from 0 to 42 points. Depending on the result, a distinction is made from Minor stroke to Severe stroke | at 96 hours | 
| all-cause mortality at 3 and 12 months |  | at 3 and 12 months | 
| Cognitive decline | Cognitive decline defined as a score on MOCA test below 27 | at 3 months, at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra Cerebral Hemorrhage, Perihaematomal oedema, MRI, outcome