Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial
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.
• 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)