Influence of Cerebral Oedema in Intracerebral Haemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Brain MRI
- Biological biomarkers
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital, Lille
Lead sponsor
Conseil Régional Hauts-de-France, France
Collaborator
Fondation pour la recherche sur les AVC
Collaborator
Source ClinicalTrials.gov