Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Intracerebral Hemorrhage (ICH)
• Intervention / Treatment: Procedure: hematoma evacuation

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jehuda Soleman, PD Dr. med.; Phone Number: +41 61 328 6076; Email: jehuda.soleman@usb.ch
• Study Contact Backup: Name: Leo Bonati, Prof. Dr. med.; Phone Number: +41 61 556 5442; Email: leo.bonati@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Neurology, University Hospital Basel
  • Basel, Switzerland, 4031
    • Department of Neurosurgery, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hematoma evacuation; Early minimally invasive image guided hematoma evacuation	Procedure: hematoma evacuation; early minimally invasive image guided hematoma evacuation in patients suffering from ICH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in hematoma volume to ≤15 mL	Change in hematoma volume to ≤15 mL	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)	6 month after treatment onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in relative (percentage) hematoma volume	Change in relative (percentage) hematoma volume	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.	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))	from baseline to 6 months
Total time spent on the intensive care unit	Total time spent on the intensive care unit	from baseline to hospital discharge (approx. 1 month)
Total time spent in intubation	Total time spent in intubation	from baseline to hospital discharge (approx. 1 month)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss Heart Foundation
• Investigators: Principal Investigator: Jehuda Soleman, PD Dr. med., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pilot study; endoscopic evacuation; spontaneous supratentorial Intracerebral Hemorrhage (SSICH); minimally invasive image guided endoscopic surgery; early hematoma evacuation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 2021-00161, ko21Bonati

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No