Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Poor functional outcome defined as a modified Rankin Scale of 4 or more
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patient with intracerebral haemorrhage
Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.
Intervention: Brain MRI (Radiation)
Patient with intracerebral haemorrhage
Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.
Intervention: Biological biomarkers (Biological)
Outcomes
Primary Outcomes
Poor functional outcome defined as a modified Rankin Scale of 4 or more
Time Frame: at 3 months
Secondary Outcomes
- Early neurological deterioration defined as more than 4 points on the NIHSS score(at 96 hours)
- all-cause mortality at 3 and 12 months(at 3 and 12 months)
- overall distribution of the modified Rankin scale at 3- and 12 months(at 3 months and 12 months)
- Cognitive decline(at 3 months, at 12 months)