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Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)
Sponsor: University Hospital, Basel, Switzerland
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.
Official title: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-01-01
Completion Date
2029-12
Last Updated
2024-07-22
Healthy Volunteers
No
Conditions
Interventions
Early minimally invasive image guided endoscopic hematoma evacuation
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.
Best medical treatment (BMT)
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
Locations (10)
Department of Neurosurgery, University Hospital Basel
Basel, Switzerland
University Hospital Bern
Bern, Switzerland
Hopitaux Universitare Geneve
Geneva, Switzerland
Centre Hopitalier Universitaire Vaudoise
Lausanne, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Centre Hopitalier Universitaire du Valais Romand
Sion, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
Universitätsspital Zürich
Zurich, Switzerland