Influence of Cerebral Oedema in Intracerebral Haemorrhage
Recruiting now · Not applicable
Conditions studied: Stroke, Intra Cerebral Hemorrhage
In brief
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
Key facts
- Study ID
- NCT04621357
- Run by
- University Hospital, Lille
- People needed
- 500
- Starts
- 2021-06-04
- Expected to finish
- 2027-12-03
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHU de Lille — Lille, France (enrolling)
Full record on ClinicalTrials.gov
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