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

Procedure: hematoma evacuation

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

Inclusion Criteria:

- No relevant disability prior to ICH (mRS 0-1 prior to ICH)

- Primary supratentorial deep or superficial intraparenchymal ICH of volume = 20 mL <
100 mL (measured using formula) demonstrated on CT or MRI, with or without a 2
component of intraventricular haemorrhage

- CT/MRI demonstrates ICH stability (< 5 mL growth) at 6 hours after the admission scan
if surgery is performed >6 hours after admission CT

- NIHSS = 8 OR if a patient with a NIHSS<8 presents with at least one of the following
deficits:

- a severe hemiparesis (4 motor points on the NIHSS for facial palsy, motoric upper
and lower extremities combined); OR

- a severe motor or sensory aphasia (2 points on the NIHSS); OR

- a profound hemi-inattention (formerly neglect, 2 points on the NIHSS); OR

- a decreased level of consciousness (GCS<13)

- Presenting GCS 5 - 15

- Endoscopic haematoma evacuation can be initiated within 24 hours of symptom onset

- Systolic blood pressure can be controlled at <160 mmHg

Exclusion Criteria:

- Imaging:

- "Spot sign" identified on CT angiography (CTA)

- Structural vascular or brain lesion as suspected cause of ICH, such as a vascular
malformation (cavernous malformation, arteriovenous malformation (AVM) etc),
aneurysm, neoplasm

- Haemorrhagic conversion of an underlying ischemic stroke

- Infratentorial haemorrhage

- Large associated intra-ventricular haemorrhage requiring treatment for related
mass effect or shift due to trapped ventricle (extraventricular drainage (EVD)
for intracranial pressure (ICP) management is allowed)

- Midbrain extension/involvement

- Coagulation Issues:

- Oral or parenteral therapeutic anticoagulation which cannot be pharmacologically
reverted until the planned time of evacuation

- Known hereditary or acquired haemorrhagic diathesis, coagulation factor
deficiency

- Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction

- international normalized ratio (INR) > 1.5 for any reason, elevated prothrombin
time or activated partial thromboplastin time (aPTT), which cannot be corrected
or otherwise accounted for (i.e., lupus anti-coagulant)

- Presenting GCS 3 or 4

- Requirement for emergent surgical decompression or uncontrolled ICP after EVD

- Unable to obtain consent from patient or appropriate surrogate (for patients without
competence)

- Pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] (woman
of child-bearing potential must have a negative history of current pregnancy prior to
the study procedure)

- Evidence of active infection (indicated by fever =38?C) at the time of study inclusion

- Any comorbid disease or condition expected to compromise survival or ability to
complete follow-up assessments through 180 days

- Based on physician's judgment, patient does not have the necessary mental capacity to
participate or is unwilling or unable to comply with protocol follow up appointment
schedule

- Active drug or alcohol use or dependence