Influence of Cerebral Oedema in Intracerebral Haemorrhage

NCT04621357 | Recruiting DMC

• 2 other identifiers: 2017_702019-A02502-55
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Intra Cerebral Hemorrhage

Keywords

Intra Cerebral Hemorrhage; Perihaematomal oedema; MRI; outcome

Outcome Measures

Primary Outcomes (1)

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

  at 3 months

Secondary Outcomes (4)

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

  at 3 months and 12 months

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

  at 96 hours

• all-cause mortality at 3 and 12 months

  at 3 and 12 months

• Cognitive decline

  at 3 months, at 12 months

Study Arms (1)

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

Brain MRI RADIATION

Brain MRI will include differents sequences.

Patient with intracerebral haemorrhage

Biological biomarkers BIOLOGICAL

Biological biomarkers will include a set of systemic inflammatory markers

Patient with intracerebral haemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Conseil Régional Hauts-de-France, France: collaborator
• Fondation pour la recherche sur les AVC: collaborator

Study Sites (1)

CHU de Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte Cordonnier, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Cordonnier, MD,PhD

CONTACT

0320445962; charlotte.cordonnier@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 9, 2020
• Study Start: June 4, 2021
• Primary Completion (Estimated): December 3, 2027
• Study Completion (Estimated): December 3, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Locations

FR (1)