Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (NCT04805177) | Clinical Trial Compass
CompletedNot Applicable
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage
Switzerland11 participantsStarted 2021-08-08
Plain-language 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Level of disability
Timeframe: 6 month after treatment onset
2
Change in hematoma volume to ≤15 mL
Timeframe: from baseline to 24 hours after treatment