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Search / Trial NCT04621357

Influence of Cerebral Oedema in Intracerebral Haemorrhage

Launched by UNIVERSITY HOSPITAL, LILLE · Nov 5, 2020

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Intra Cerebral Hemorrhage Perihaematomal Oedema Mri Outcome

ClinConnect Summary

The COPITCH study is investigating a type of stroke known as Intracerebral Hemorrhage (ICH), which occurs when there is bleeding inside the brain. This research aims to understand the role of swelling around the bleeding area, called perihaematomal oedema (PHO), and how it affects recovery and treatment options. Currently, there are no specific proven treatments for this condition, so the study hopes to find new ways to help patients who experience ICH.

To participate in this study, individuals should be between the ages of 65 and 74 and have had a spontaneous (non-traumatic) ICH within the last 12 hours. Participants must also be insured under the French social security system and provide consent to join the study. Those with certain conditions, such as previous brain injuries or serious health issues that limit life expectancy, will not be eligible. If you join the study, you can expect to undergo assessments and possibly MRI scans to help researchers learn more about the effects of PHO on recovery from stroke. This research could lead to better treatments for future patients experiencing similar health challenges.

Gender

ALL

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

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Lille, , France

Patients applied

0 patients applied

Trial Officials

Charlotte Cordonnier, MD,PhD

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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