Minimally invasive endoscopic treatment for brain hemorrhage
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial
This study tests if a new, less invasive method to remove blood clots in the brain can help people with brain hemorrhages recover better than just using standard medical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 10 sites (Basel and 9 other locations) |
| Trial ID | NCT05681988 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of early minimally invasive image-guided endoscopic evacuation of hematomas in patients with spontaneous supratentorial intracerebral hemorrhage (SSICH), compared to best medical treatment alone. The study aims to determine if this approach can improve functional outcomes at six months post-treatment. Participants will undergo a series of assessments, including Glasgow Coma Scale evaluations, throughout the trial. The intervention is designed to be initiated within 24 hours of symptom onset to maximize potential benefits.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with spontaneous supratentorial intracerebral hemorrhage with specific neurological deficits and hematoma volumes between 20 mL and 100 mL.
Not a fit: Patients with hemorrhages outside the specified volume range or those who cannot undergo endoscopic evacuation within the required timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and survival rates for patients suffering from intracerebral hemorrhage.
How similar studies have performed: While endoscopic surgery has shown promise in smaller studies, large trials analyzing its benefits in this context are lacking, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Basel and 9 other locations
- Department of Neurosurgery, University Hospital Basel — Basel, Switzerland (Recruiting)
- University Hospital Bern — Bern, Switzerland (Recruiting)
- Hopitaux Universitare Geneve — Geneva, Switzerland (Recruiting)
- Centre Hopitalier Universitaire Vaudoise — Lausanne, Switzerland (Recruiting)
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
- Ospedale Regionale di Lugano — Lugano, Switzerland (Recruiting)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Centre Hopitalier Universitaire du Valais Romand — Sion, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
- Universitätsspital Zürich — Zurich, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Jehuda Soleman, Prof. Dr. med. — Department of Neurosurgery, University Hospital Basel
- Study coordinator: Raphael Guzman, Prof. Dr. med.
- Email: raphael.guzman@usb.ch
- Phone: +41 61 265 33 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.