200
Participants
Start Date
January 1, 2024
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2029
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
RECRUITING
Department of Neurosurgery, University Hospital Basel, Basel
RECRUITING
University Hospital Bern, Bern
RECRUITING
Hopitaux Universitare Geneve, Geneva
RECRUITING
Centre Hopitalier Universitaire Vaudoise, Lausanne
RECRUITING
Luzerner Kantonsspital, Lucerne
RECRUITING
Ospedale Regionale di Lugano, Lugano
RECRUITING
Kantonsspital St. Gallen, Sankt Gallen
RECRUITING
Centre Hopitalier Universitaire du Valais Romand, Sion
RECRUITING
Kantonsspital Winterthur, Winterthur
NOT_YET_RECRUITING
Universitätsspital Zürich, Zurich
Swiss National Science Foundation
OTHER
University Hospital, Geneva
OTHER
Cantonal Hospital of St. Gallen
OTHER
Ospedale Regionale di Lugano
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Hôpital du Valais
OTHER
University Hospital, Zürich
OTHER
Kantonsspital Winterthur KSW
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Luzerner Kantonsspital
OTHER
University Hospital, Basel, Switzerland
OTHER