Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage

Intracerebral Hemorrhage (ICH) Clinical Trial

Official title:

Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage: a Prospective Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04805177
• Other study ID #: 2021-00161, ko21Bonati
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2021
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 (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
• 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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage (ICH)

Intervention

Procedure:
• hematoma evacuation
early minimally invasive image guided hematoma evacuation in patients suffering from ICH

Locations

Country	Name	City	State
Switzerland	Department of Neurology, University Hospital Basel	Basel
Switzerland	Department of Neurosurgery, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss Heart Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month after treatment onset
Primary	Change in hematoma volume to =15 mL	Change in hematoma volume to =15 mL	from baseline to 24 hours after treatment
Primary	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)	6 month after treatment onset
Secondary	Change in relative (percentage) hematoma volume	Change in relative (percentage) hematoma volume	from baseline to 24 hours after treatment
Secondary	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.	from baseline to 6 months
Secondary	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))	from baseline to 6 months
Secondary	Total time spent on the intensive care unit	Total time spent on the intensive care unit	from baseline to hospital discharge (approx. 1 month)
Secondary	Total time spent in intubation	Total time spent in intubation	from baseline to hospital discharge (approx. 1 month)