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Influence of Cerebral Oedema in Intracerebral Haemorrhage

ConditionsStrokeIntra Cerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Brain MRI

    Radiation

    Brain MRI will include differents sequences.

  • Biological biomarkers

    Biological/Vaccine

    Biological biomarkers will include a set of systemic inflammatory markers

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patient with intracerebral haemorrhageExperimental treatment 2 interventions

Trial outcomes

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

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.

Time frame
at 3 months and 12 months
2

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

Time frame
at 96 hours
3

all-cause mortality at 3 and 12 months

Time frame
at 3 and 12 months
4

Cognitive decline

Cognitive decline defined as a score on MOCA test below 27

Time frame
at 3 months, at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Conseil Régional Hauts-de-France, France

Collaborator

Fondation pour la recherche sur les AVC

Collaborator

Source ClinicalTrials.gov
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