At a glance
ClinicalIndex Comparison Record- ✓Spontaneous supratentorial intracerebral hemorrhage (SSICH) with lobar and/or basal ganglia and/or thalamic involvement
- ✓ICH volume between 20 and 100 mL
- ✓Clinically relevant focal neurological deficit: hemiparesis (≥4 NIHSS motor points), motor/sensory aphasia (≥2 NIHSS points), or hemi-inattention (2 NIHSS points)
- ✓Decreased level of consciousness with GCS ≤13
- ✕SSICH due to structural abnormality: vascular malformation, aneurysm, AVM, brain tumor, trauma, or hemorrhagic conversion of ischemic infarction
- ✕Multiple simultaneous intracranial hemorrhages including multifocal ICH, cSDH, aSDH, or SAH
- ✕Infratentorial hemorrhage or midbrain extension/involvement
- ✕Coagulation disorder with INR >1.5 that cannot be pharmacologically reverted before evacuation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial
In Brief
A clinical study evaluating Early minimally invasive image guided endoscopic hematoma evacuation and Best medical treatment (BMT) for Intracerebral Haemorrhage. Currently recruiting, targeting 200 participants across 10 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
The intervention group will first receive BMT (as defined below) upon admission and early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT. Surgery will be performed within 6-24 hours after SSICH symptom onset. Surgery will be performed in an emergency operating theatre or a hybrid operation theatre equipped with intraoperative CT (in hybrid OR), neuronavigation, and neuro-endoscopy.The position and progress of the trocar towards the hematoma cavity will be monitored with neuro-navigation. The endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent) will be inserted into the trocar and tracked using neuro-navigation. Using the pre-planned trajectory, the hematoma will be entered. Using continuous suction and irrigation, the hematoma will be aspirated and/or washed out.
The control group will receive the current gold standard treatment for SSICH according to the guidelines (BMT). This involves strict blood pressure control (SBP\<140mmHg), if needed with intravenous or intraarterial blood pressure lowering agents, reversal of anticoagulation if applicable, intensive care surveillance and nursing on a ICU or stroke unit, control of seizures as well as glucose levels as needed and neurointensive monitoring if deemed necessary