Influence of Cerebral Oedema in Intracerebral Haemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain MRI, Biological biomarkers.
- Who it may be relevant to
- Registry conditions: Stroke, Intra Cerebral Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
Overview
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
Interventions
- Radiation Brain MRI
Brain MRI will include differents sequences. - Biological Biological biomarkers
Biological biomarkers will include a set of systemic inflammatory markers
Primary outcome measures
- Poor functional outcome defined as a modified Rankin Scale of 4 or more [Time frame: at 3 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHU de Lille — Lille
Identifiers
NCT: NCT04621357 · 2017_70 · 2019-A02502-55