Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage: a Prospective Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracerebral Hemorrhage (ICH)
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- number of specific adverse events (AE)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •"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
Outcomes
Primary Outcomes
number of specific adverse events (AE)
Time Frame: 6 month after treatment onset
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)
Change in hematoma volume to ≤15 mL
Time Frame: from baseline to 24 hours after treatment
Change in hematoma volume to ≤15 mL
Level of disability
Time Frame: 6 month after treatment onset
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.
Secondary Outcomes
- Change in relative (percentage) hematoma volume(from baseline to 24 hours after treatment)
- Change of serum biomarkers of brain injury(from baseline to 6 months)
- Total time spent on the intensive care unit(from baseline to hospital discharge (approx. 1 month))
- Change of focal neurological deficit measured by the NIHSS(from baseline to 6 months)
- Total time spent in intubation(from baseline to hospital discharge (approx. 1 month))