Influence of Cerebral Oedema in Intracerebral Haemorrhage (COPITCH)

University Hospital, Lille

Status: Enrolling

Conditions: Intra Cerebral Hemorrhage; Stroke

Treatments: Radiation: Brain MRI; Biological: Biological biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT04621357

2019-A02502-55 (Other Identifier)

2017_70

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

500 participants in 1 patient group

Patient with intracerebral haemorrhage

Experimental group

Description:

Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.

Treatment:

Biological: Biological biomarkers

Radiation: Brain MRI