Frühe, minimal invasive, bildgebungsgesteuerte endoskopische Ausräumung von Hirngewebsblutungen: Eine randomisierte Studie

Procedure: Early minimally invasive image guided endoscopic hematoma evacuation;Procedure: Best medical treatment (BMT)

Gender: All
Maximum age: 85 Years
Minimum age: 18 Years

Inclusion Criteria:

- 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)

- clinically relevant motor or sensory aphasia (=2 points on the NIHSS)

- clinically relevant hemi-inattention (formerly neglect, 2 points on the NIHSS)

- decreased level of consciousness (Glasgow Coma Scale (GCS)=13)

- Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after
Rutledge et al. or if impossible, the last pre-intubation GCS will be used)

- Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was
last seen well/symptom onset

- Informed consent of patient or appropriate surrogate (for patients without competence)

Exclusion Criteria:

- 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

- Pregnancy

- Relevant disability prior to SSICH (mRS >2)

- Any comorbid disease or condition expected to compromise survival or ability to
complete follow-up assessments through 180 days (e.g. bilateral fixed dilated pupils)