Influence of Cerebral Oedema in Intracerebral Haemorrhage (NCT04621357) | Clinical Trial Compass
RecruitingNot Applicable
Influence of Cerebral Oedema in Intracerebral Haemorrhage
France500 participantsStarted 2021-06-04
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Poor functional outcome defined as a modified Rankin Scale of 4 or more