Influence of Cerebral Oedema in Intracerebral Haemorrhage

Not Applicable

Recruiting

• Conditions: Stroke; Intra Cerebral Hemorrhage
• Interventions: Radiation: Brain MRI; Biological: Biological biomarkers

• Registration Number: NCT04621357
• Lead Sponsor: University Hospital, Lille

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-09
• Study Start: 2021-06-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with intracerebral haemorrhage	Brain MRI	Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.
Patient with intracerebral haemorrhage	Biological biomarkers	Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.

Primary Outcome Measures

Name	Time	Method
Poor functional outcome defined as a modified Rankin Scale of 4 or more	at 3 months

Secondary Outcome Measures

Name	Time	Method
Early neurological deterioration defined as more than 4 points on the NIHSS score	at 96 hours	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
all-cause mortality at 3 and 12 months	at 3 and 12 months
overall distribution of the modified Rankin scale at 3- and 12 months	at 3 months 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.
Cognitive decline	at 3 months, at 12 months	Cognitive decline defined as a score on MOCA test below 27

Trial Locations

Locations (1)

CHU de Lille; 🇫🇷 Lille, France