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Influence of Cerebral Oedema in Intracerebral Haemorrhage (COPITCH)

Primary Purpose

Stroke, Intra Cerebral Hemorrhage

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Brain MRI

Biological biomarkers

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Intra Cerebral Hemorrhage, Perihaematomal oedema, MRI, outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with intracerebral haemorrhage

Arm Description

Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.

Outcomes

Primary Outcome Measures

Poor functional outcome defined as a modified Rankin Scale of 4 or more

Secondary Outcome Measures

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.

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

all-cause mortality at 3 and 12 months

Cognitive decline

Cognitive decline defined as a score on MOCA test below 27

Full Information

NCT ID

NCT04621357

First Posted

October 29, 2020

Last Updated

November 5, 2020

Sponsor

University Hospital, Lille

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04621357

Brief Title

Influence of Cerebral Oedema in Intracerebral Haemorrhage

Acronym

COPITCH

Official Title

Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Intra Cerebral Hemorrhage

Keywords

Intra Cerebral Hemorrhage, Perihaematomal oedema, MRI, outcome

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient with intracerebral haemorrhage

Arm Type

Experimental

Arm Description

Patients will be screened at admission in the stroke units right after brain MRI demonstrating the presence of blood in the brain parenchyma.

Intervention Type

Radiation

Intervention Name(s)

Brain MRI

Intervention Description

Brain MRI will include differents sequences.

Intervention Type

Biological

Intervention Name(s)

Biological biomarkers

Intervention Description

Biological biomarkers will include a set of systemic inflammatory markers

Primary Outcome Measure Information:

Title

Poor functional outcome defined as a modified Rankin Scale of 4 or more

Time Frame

at 3 months

Secondary Outcome Measure Information:

Title

overall distribution of the modified Rankin scale at 3- and 12 months

Description

Time Frame

at 3 months and 12 months

Title

Early neurological deterioration defined as more than 4 points on the NIHSS score

Description

Time Frame

at 96 hours

Title

all-cause mortality at 3 and 12 months

Time Frame

at 3 and 12 months

Title

Cognitive decline

Description

Cognitive decline defined as a score on MOCA test below 27

Time Frame

at 3 months, at 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charlotte Cordonnier, MD,PhD

Phone

0320445962

charlotte.cordonnier@chru-lille.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charlotte Cordonnier, MD,PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Influence of Cerebral Oedema in Intracerebral Haemorrhage

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