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NCT Number: NCT04621357

Influence of Cerebral Oedema in 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Lille

Lille, 59037, France

Location status: Recruiting

Location contact

CORDONNIER Charlotte, MHD, PHD

CONTACT

[email protected]

0320446814 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brain MRI

Radiation

Brain MRI will include differents sequences.

Biological biomarkers

Biological

Biological biomarkers will include a set of systemic inflammatory markers

Primary outcomes

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

    Time frame: at 3 months

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Cordonnier, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Official study title

Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage

Acronym: COPITCH

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 9, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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