StrokeCOPITCHNCT04621357
Influence of Cerebral Oedema in Intracerebral Haemorrhage
A study testing Brain MRI and Biological biomarkers in people with Stroke and Intra Cerebral Hemorrhage, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Intra Cerebral Hemorrhage
- What is being tested?
- Brain MRI and Biological biomarkers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2021to 3 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille, 59037
CORDONNIER Charlotte, MHD, PHD, 0320446814 ext. +33, charlotte.cordonnier@chu-lille.fr
About this study
Official title: Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
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
- Conditions
- Stroke, Intra Cerebral Hemorrhage
- Being tested
- Brain MRI, Biological biomarkers
- Keywords
- Intra Cerebral Hemorrhage, Perihaematomal oedema, MRI, outcome
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIRadiation
Brain MRI will include differents sequences.
Biological biomarkersBiological
Biological biomarkers will include a set of systemic inflammatory markers
| Study group | Role | What they receive |
|---|---|---|
| Patient with intracerebral haemorrhage | Experimental | Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma. Receives: Radiation: Brain MRI; Biological: Biological biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor functional outcome defined as a modified Rankin Scale of 4 or more
Measured: at 3 months
Secondary outcomes (4)
overall distribution of the modified Rankin scale at 3- and 12 months
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6, running from perfect health without symptoms to death.
Measured: at 3 months and 12 months
Early neurological deterioration defined as more than 4 points on the NIHSS score
The NIHSS score (NIH Stroke Scale) is used to monitor the progression of an ischemic or hemorrhagic stroke. It is rated from 0 to 42 points. Depending on the result, a distinction is made from Minor stroke to Severe stroke
Measured: at 96 hours
all-cause mortality at 3 and 12 months
Measured: at 3 and 12 months
Cognitive decline
Cognitive decline defined as a score on MOCA test below 27
Measured: at 3 months, at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start4 Jun 2021
- Primary completion3 Dec 2027 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Conseil Régional Hauts-de-France, France, Fondation pour la recherche sur les AVC
- Responsible party
- Sponsor
- Investigators
- Charlotte Cordonnier, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621357
- Sponsor's protocol ID
- 2017_70
- Other IDs
- 2019-A02502-55
- Acronym
- COPITCH
- Status last verified
- Mar 2026
- First submitted
- 29 Oct 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
- ClinicalTrials.gov ID
- NCT04621357
- Acronym / sponsor ID
- COPITCH / 2017_70
- Conditions
- Stroke, Intra Cerebral Hemorrhage
- Keywords
- Intra Cerebral Hemorrhage, Perihaematomal oedema, MRI, outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Conseil Régional Hauts-de-France, France, Fondation pour la recherche sur les AVC
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 3 Dec 2027 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with intracerebral haemorrhage | Experimental | Radiation: Brain MRI, Biological: Biological biomarkersPatients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIBrain MRI will include differents sequences. | Radiation | Patient with intracerebral haemorrhage |
| Biological biomarkersBiological biomarkers will include a set of systemic inflammatory markers | Biological | Patient with intracerebral haemorrhage |
Primary outcome
Poor functional outcome defined as a modified Rankin Scale of 4 or more
Time frame: at 3 months
4 secondary outcomes
overall distribution of the modified Rankin scale at 3- and 12 months
Time frame: at 3 months and 12 months
Early neurological deterioration defined as more than 4 points on the NIHSS score
Time frame: at 96 hours
all-cause mortality at 3 and 12 months
Time frame: at 3 and 12 months
Cognitive decline
Time frame: at 3 months, at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Cordonnier, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI and Biological biomarkers in people with Stroke and Intra Cerebral Hemorrhage, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Cordonnier, MD,PhD (0320445962 ext. +33, charlotte.cordonnier@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor functional outcome defined as a modified Rankin Scale of 4 or more (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.