Influence of Cerebral Oedema in Intracerebral Haemorrhage

Stroke Clinical Trial

— COPITCH  

Official title:

Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04621357
• Other study ID #: 2017_70
• Secondary ID: 2019-A02502-55
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: Charlotte Cordonnier, MD,PhD
• Phone: 0320445962
• Email: charlotte.cordonnier[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intra Cerebral Hemorrhage
• Stroke

Intervention

Radiation:
• Brain MRI
Brain MRI will include differents sequences.

Biological:
• Biological biomarkers
Biological biomarkers will include a set of systemic inflammatory markers

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Conseil Régional Hauts-de-France, France, Fondation pour la recherche sur les AVC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Poor functional outcome defined as a modified Rankin Scale of 4 or more		at 3 months
Secondary	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.	at 3 months and 12 months
Secondary	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	at 96 hours
Secondary	all-cause mortality at 3 and 12 months		at 3 and 12 months
Secondary	Cognitive decline	Cognitive decline defined as a score on MOCA test below 27	at 3 months, at 12 months