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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
early minimally invasive image guided hematoma evacuation in patients suffering from ICH
Department of Neurology, University Hospital Basel
Basel, Switzerland
Department of Neurosurgery, University Hospital Basel
Basel, Switzerland
Level of disability
level of disability 6 months after treatment, measured by the modified Rankin Scale (mRS). Good functional outcome is defined by a score on the mRS of ≤3.
Time frame: 6 month after treatment onset
Change in hematoma volume to ≤15 mL
Change in hematoma volume to ≤15 mL
Time frame: from baseline to 24 hours after treatment
number of specific adverse events (AE)
number of specific adverse events (AE) (death, ischemic stroke, recurrent ICH (defined as any increase in hematoma volume at follow-up that is associated with a worsening of the focal-neurological deficit by ≥4 points on the National Institute of Health Stroke Scale (NIHSS) and/or a decrease in consciousness by ≥2 points on the Glasgow Coma Scale (GCS), epileptic seizure, infection, any need for open neurosurgical procedures)
Time frame: 6 month after treatment onset
Change in relative (percentage) hematoma volume
Change in relative (percentage) hematoma volume
Time frame: from baseline to 24 hours after treatment
Change of focal neurological deficit measured by the NIHSS
Change of focal neurological deficit measured by the NIHSS. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
Time frame: from baseline to 6 months
Change of serum biomarkers of brain injury
Change of serum biomarkers of brain injury (light-chain neurofilament subunit (NfL), the Glial Fibrillary Acidic Protein (GFAP) and the S100 calcium-binding protein B (S100B))
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Time frame: from baseline to 6 months
Total time spent on the intensive care unit
Total time spent on the intensive care unit
Time frame: from baseline to hospital discharge (approx. 1 month)
Total time spent in intubation
Total time spent in intubation
Time frame: from baseline to hospital discharge (approx. 1 month)