Actively Recruiting
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)
Led by University Hospital, Basel, Switzerland · Updated on 2024-07-22
200
Participants Needed
10
Research Sites
308 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spontaneous supratentorial intracerebral hemorrhage confirmed by imaging
- Hematoma volume between 20 mL and less than 100 mL
- Focal neurological deficit including clinically relevant hemiparesis, motor or sensory aphasia, hemi-inattention, or decreased level of consciousness
- Glasgow Coma Scale (GCS) score between 5 and 15
- Endoscopic hematoma evacuation can be initiated within 24 hours of symptom onset
- Informed consent provided by patient or appropriate surrogate
You will not qualify if you...
- SSICH caused by structural brain abnormalities, brain trauma, or hemorrhagic conversion of ischemic infarction
- Multiple simultaneous intracranial hemorrhages such as multifocal ICH, chronic or acute subdural hematoma, or subarachnoid hemorrhage
- Infratentorial hemorrhage or midbrain involvement
- Coagulation disorder with INR >1.5 not reversible before planned evacuation
- Pregnancy
- Significant disability prior to SSICH (mRS >2)
- Any comorbid condition expected to limit survival or ability to complete 180-day follow-up assessments
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Department of Neurosurgery, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
2
University Hospital Bern
Bern, Switzerland
Actively Recruiting
3
Hopitaux Universitare Geneve
Geneva, Switzerland
Actively Recruiting
4
Centre Hopitalier Universitaire Vaudoise
Lausanne, Switzerland
Actively Recruiting
5
Luzerner Kantonsspital
Lucerne, Switzerland
Actively Recruiting
6
Ospedale Regionale di Lugano
Lugano, Switzerland
Actively Recruiting
7
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
8
Centre Hopitalier Universitaire du Valais Romand
Sion, Switzerland
Actively Recruiting
9
Kantonsspital Winterthur
Winterthur, Switzerland
Actively Recruiting
10
Universitätsspital Zürich
Zurich, Switzerland
Not Yet Recruiting
Research Team
R
Raphael Guzman, Prof. Dr. med.
CONTACT
T
Tim Hallenberger, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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