The primary objective is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in functional outcome rates at 6 months in patients with SSICH.

Secondary objectives are

• to show superior survival rates of patients in the ES arm

• to study patient reported quality of life after treatment for SSICH at different time points (3 and 6 months after intervention)

• to study patient satisfaction with the outcome after treatment for SSICH at different time points (3 months and 6 months after intervention)

• to study cognitive outcome in patients after treatment for SSICH at different time points (3 months and 6 months after intervention)

• to study the morbidity rates of patients in both treatment arms

• to study the efficacy of ES in reducing the hematoma volume

• to study the change in focal neurological deficits exhibited by the patients after treatment. 

• to study the temporal evolution of serum biomarkers (Neurofilament light-chain subunit (NfL), Glial Fibrillary Acidic Protein (GFAP), S100 calcium-binding protein B (S100), IL-2, IL-4, IL-6, IL-8, IL-10 and TNF-α) and their change in relation to early hematoma ES.

Primary outcome

• Good functional outcome 6 months after treatment, measured by the mRS. Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome at 6 months after treatment.

Secondary outcomes

• The mortality rate as measured by death of a participant at 6 months after intervention.

• Patient reported outcome measures at 3 and 6 months after intervention, those being:

  • Patient and caregiver quality of life as assessed by the PROMIS® questionnaire

  • Patient Satisfaction as assessed by a short survey on a scale of 1-5 

  • Patient cognitive outcome as assessed by the MOCA® Test

• 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.

• The change of focal neurological deficit measured by the NIHSS, from baseline to 6 months after intervention as a continuous variable

• The time to intervention, defined as the period from symptom onset/last seen well to start of surgery (start surgical measures, i.e. positioning of patient) or start of medical treatment (admission of first treatment of BMT)

• The temporal evolution of serum levels of the prespecified biomarkers as continuous variable from start to 6 months after intervention

• The total time spent on the intensive care unit (ICU)/stroke unit as a continuous variable from the first admission to the ICU/stroke unit to discharge from ICU/stroke unit at 7 days/discharge after intervention

• The total time spent in intubation measured in minutes from the start of intubation to extubation as specified in the anesthesiology report at 7 days/discharge after intervention

Outcomes/Measurements applying to the intervention group only

• The proportion of hematoma volume reduction rate (goal ≤15% of its initial volume). The hematoma volume reduction rate will be a binary variable

• The relative (percentage) reduction or increase of hematoma volume from baseline admission cCT to postoperative cCT directly after surgery as a continuous variable (final value).