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.
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)
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
University Hospital, Basel, Switzerland
Lead sponsor
Swiss National Science Foundation
Collaborator
University Hospital, Geneva
Collaborator
Cantonal Hospital of St. Gallen
Collaborator
Ospedale Regionale di Lugano
Collaborator
Centre Hospitalier Universitaire Vaudois
Collaborator
Hôpital du Valais
Collaborator
University Hospital, Zürich
Collaborator
Kantonsspital Winterthur KSW
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Luzerner Kantonsspital
Collaborator