NCT04621357Recruiting
Influence of Cerebral Oedema in Intracerebral Haemorrhage
Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 29 Oct 2020
- Start date
- 4 Jun 2021
- Primary completion date
- 3 Dec 2027
- Lead sponsor
- University Hospital, Lille
- Diseases
- Stroke
- NCT number
- NCT04621357
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 4 Jun 2021 to the primary completion date, 3 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- "secondary" ICH: ICH resulting from intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour; haemorrhagic transformation within an infarct
- Life expectancy of less than 1 year related to comorbidities (end stage cancer, end stage organ failure)
Age
- Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
Other
- Pure intraventricular haemorrhages
- Pre-admission modified Rankin score of 4 or 5
- Adults who are deprived of their liberty by judicial or administrative decision
- Referral from other hospitals
- No consent form
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.