Influence of Cerebral Oedema in Intracerebral Haemorrhage (COPITCH)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Intra Cerebral Hemorrhage
• Intervention / Treatment: Radiation: Brain MRI; Biological: Biological biomarkers

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte Cordonnier, MD,PhD; Phone Number: 0320445962; Email: charlotte.cordonnier@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patient with intracerebral haemorrhage; Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.	Radiation: Brain MRI; Brain MRI will include differents sequences.; Biological: Biological biomarkers; Biological biomarkers will include a set of systemic inflammatory markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Poor functional outcome defined as a modified Rankin Scale of 4 or more	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	at 96 hours
all-cause mortality at 3 and 12 months		at 3 and 12 months
Cognitive decline	Cognitive decline defined as a score on MOCA test below 27	at 3 months, at 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Conseil Régional Hauts-de-France, France; Fondation pour la recherche sur les AVC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (ACTUAL): November 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: MRI; outcome; Intra Cerebral Hemorrhage; Perihaematomal oedema
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 2017_70; 2019-A02502-55 (OTHER: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No