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Influence of Cerebral Oedema in Intracerebral Haemorrhage (COPITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621357
Recruitment Status : Not yet recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Collaborators:
Conseil Régional Hauts-de-France, France
Fondation pour la recherche sur les AVC
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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

Condition or disease Intervention/treatment Phase
Stroke Intra Cerebral Hemorrhage Radiation: Brain MRI Biological: Biological biomarkers Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Edema

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Poor functional outcome defined as a modified Rankin Scale of 4 or more [ Time Frame: at 3 months ]

Secondary Outcome Measures :
  1. overall distribution of the modified Rankin scale at 3- and 12 months [ Time Frame: 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.


  2. Early neurological deterioration defined as more than 4 points on the NIHSS score [ Time Frame: 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

  3. all-cause mortality at 3 and 12 months [ Time Frame: at 3 and 12 months ]
  4. Cognitive decline [ Time Frame: at 3 months, at 12 months ]
    Cognitive decline defined as a score on MOCA test below 27


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621357


Contacts
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Contact: Charlotte Cordonnier, MD,PhD 0320445962 charlotte.cordonnier@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Conseil Régional Hauts-de-France, France
Fondation pour la recherche sur les AVC
Investigators
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Principal Investigator: Charlotte Cordonnier, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04621357    
Other Study ID Numbers: 2017_70
2019-A02502-55 ( Other Identifier: ID-RCB number,ANSM )
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Intra Cerebral Hemorrhage
Perihaematomal oedema
MRI
outcome
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases