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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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