Influence of Cerebral Oedema in Intracerebral Haemorrhage | NCT04621357

Studies
Influence of Cerebral Oedema in Intracerebral Haemorrhage

NCT04621357

Sponsor

University Hospital, Lille

Status

Recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Stroke
Intra Cerebral Hemorrhage

Interventions

Brain MRI
Biological biomarkers

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A02502-55	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2021Actual

Primary Completion Date

Dec 3, 2027Estimated

Completion Date

Dec 3, 2027Estimated

First Submitted Date

Oct 29, 2020

First Submission Date that Met QC Criteria

Nov 5, 2020

First Posted Date

Nov 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 22, 2026Actual

Name	Class
Conseil Régional Hauts-de-France, France	UNKNOWN
Fondation pour la recherche sur les AVC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with intracerebral haemorrhage	Experimental	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 Biological: Biological biomarkers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brain MRI	Radiation	Brain MRI will include differents sequences.	Patient with intracerebral haemorrhage

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charlotte Cordonnier, MD,PhD	Contact	0320445962	+33	charlotte.cordonnier@chu-lille.fr

Overall Officials

Name	Affiliation	Role
Charlotte Cordonnier, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Lille	Recruiting	Lille		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided