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
Parallel
Early minimally invasive image guided endoscopic hematoma evacuation
Procedure/SurgeryThe 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)
Procedure/SurgeryThe 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
Good functional outcome, measured by the modified Rankin Scale (mRS)
Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome (yes/no, final value). In this context, a mRS score of 3 points reflects the ability to walk unassisted and care for one's own bodily needs despite being moderately dependent on assistance, while a mRS score of 4 points describes a patient who is not able to walk anymore and needs assistance with all daily activities and thus marks a severe loss of patient autonomy.
Mortality rate
Mortality rate as measured by death of a participant (binary outcome (yes/no)
Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire
The PROMIS® questionnaire scores can be categorized as: within normal limits, mild, moderate and severe.
Change in Patient cognitive outcome as assessed by the Montreal-Cognitive-Assessment-Test (MOCA® )
The MOCA assesses: Short term memory. Visuospatial abilities. Executive functions. Attention, concentration and working memory. Language.18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Morbidity rate
The morbidity rate, meaning occurrence of: Ischemic stroke, Recurrent SSICH (defined as any radiologically confirmed increase in hematoma volume postoperative/follow-up that is either asymptomatic or associated with a worsening of the focal-neurological deficit by ≥4 points on the NIHSS and/or a decrease in consciousness by ≥2 points on the GCS), Epileptic seizure, Surgical site infection (intervention group only), Any need for open neurosurgical procedures, Infections (i.e. pneumonia, urinary tract infection), Any other not defined complication that prolongs the hospital stay and/or leads to further treatment not envisaged in the original treatment plan.
Click on the lead sponsor to view all of their trials.
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
