Influence of Cerebral Oedema in Intracerebral Haemorrhage

NCT ID: NCT04621357

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-04

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Stroke Intra Cerebral Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Brain MRI

Intervention Type RADIATION

Brain MRI will include differents sequences.

Biological biomarkers

Intervention Type BIOLOGICAL

Biological biomarkers will include a set of systemic inflammatory markers

Interventions

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Brain MRI

Brain MRI will include differents sequences.

Intervention Type RADIATION

Biological biomarkers

Biological biomarkers will include a set of systemic inflammatory markers

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conseil Régional Hauts-de-France, France

UNKNOWN

Sponsor Role collaborator

Fondation pour la recherche sur les AVC

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Cordonnier, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHU de Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charlotte Cordonnier, MD,PhD

Role: CONTACT

0320445962 ext. +33

Facility Contacts

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CORDONNIER Charlotte, MHD, PHD

Role: primary

0320446814 ext. +33

Other Identifiers

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2019-A02502-55

Identifier Type: OTHER

Identifier Source: secondary_id

2017_70

Identifier Type: -

Identifier Source: org_study_id

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