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Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)

RecruitingNAAges 18 Years - 85 YearsAllUniversity Hospital, Basel, Switzerland
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In plain words

What the trial is, and whether it could suit you

This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and/or into the basal ganglia and/or thalamus that may extend into the ventricles confirmed by imaging * SSICH volume ≥20 mL \<100 mL * A focal neurological deficit consisting of either * clinically relevant hemiparesis (≥4 motor points on the NIHSS for facial palsy, motoric upper and lower extremities combined) * clinically relevant motor or sensory aphasia (≥2 points on the NIHSS) * clinically relevant hemi-inattention (formerly neglect, 2 points on the NIHSS) * decreased level of consciousness (Glasgow Coma Scale (GCS)≤13) * Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after Rutledge et al. or if impossible, the last pre-intubation GCS will be used) * Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was last seen well/symptom onset * Informed consent of patient or appropriate surrogate (for patients without competence) Exclusion Criteria: * SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and/or brain trauma and/or hemorrhagic conversion of an ischemic infarction * Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronic subdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH) * Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage * Coagulation disorder (including anticoagulation) with an international normalized ratio (INR) of \>1.5 which cannot be pharmacologically reverted until the planned time of evacuation * Pregnancy * Relevant disability prior to SSICH (mRS \>2) * Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days (e.g. bilateral fixed dilated pupils)
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What it tests

  • Early minimally invasive image guided endoscopic hematoma evacuation
  • Best medical treatment (BMT)
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Where

10 sites
Department of Neurosurgery, University Hospital Basel
Basel, Switzerland
University Hospital Bern
Bern, Switzerland
Hopitaux Universitare Geneve
Geneva, Switzerland
Centre Hopitalier Universitaire Vaudoise
Lausanne, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Centre Hopitalier Universitaire du Valais Romand
Sion, Switzerland

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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