Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Intracerebral Haemorrhage
Interventions
PROCEDURE

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.

PROCEDURE

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

Trial Locations (10)

4031

RECRUITING

Department of Neurosurgery, University Hospital Basel, Basel

Unknown

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

All Listed Sponsors
collaborator

Swiss National Science Foundation

OTHER

collaborator

University Hospital, Geneva

OTHER

collaborator

Cantonal Hospital of St. Gallen

OTHER

collaborator

Ospedale Regionale di Lugano

OTHER

collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

collaborator

Hôpital du Valais

OTHER

collaborator

University Hospital, Zürich

OTHER

collaborator

Kantonsspital Winterthur KSW

OTHER

collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

collaborator

Luzerner Kantonsspital

OTHER

lead

University Hospital, Basel, Switzerland

OTHER