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

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.

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 imagingSSICH volume ≥20 mL <100 mLStable clot volume defined as absence of arterial spot sign (spot like/serpiginous appearance inside the hematoma and/or increase of >33% (as assessed using the formula (A * B * C)/2 of initial clot volume on follow-up imagingA focal neurological deficit consisting of eitherclinically 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 onsetInformed 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 infarctionMultiple 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 hemorrhageCoagulation disorder (including anticoagulation) with an international normalized ratio (INR) of >1.5 which cannot be pharmacologically reverted until the planned time of evacuationPositive history of current pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] in premenopausal womenRelevant 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)