Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage
The aim of this pilot study is to provide an assessment of safety and feasibility of early
 minimally invasive image guided endoscopic hematoma evacuation (within 24 hours of symptom
 onset) in patients suffering from intracerebral haemorrhage (ICH).
Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the is the second most common
 form of stroke. The aim of this single centre, single arm pilot study is to provide an
 assessment of safety and feasibility of early minimally invasive image guided endoscopic
 hematoma evacuation (within 24 hours of symptom onset) in patients suffering from
 intracerebral haemorrhage (ICH).

 Furthermore this study contributes to the understanding of secondary neuronal damage involved
 in ICH through the measurement of biomarkers for neuronal damage and their response to early
 hematoma evacuation.
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 ≥ 10

 -  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 at time of ICH onset

 -  Absolute requirement for long-term anti-coagulation (e.g., Mechanical valve
 replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)

 -  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