Clinical trial NCT04805177: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage
Official title: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Hemorrhage (ICH)
Keywords: endoscopic evacuation
pilot study
spontaneous supratentorial Intracerebral Hemorrhage (SSICH)
minimally invasive image guided endoscopic surgery
early hematoma evacuation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Heart Foundation
First posted: 2021-03-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm pilot study
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Level of disability
timeFrame: 6 month after treatment onset
measure: Change in hematoma volume to ≤15 mL
timeFrame: from baseline to 24 hours after treatment
measure: number of specific adverse events (AE)
timeFrame: 6 month after treatment onset
Secondary outcomes:
measure: Change in relative (percentage) hematoma volume
timeFrame: from baseline to 24 hours after treatment
measure: Change of focal neurological deficit measured by the NIHSS
timeFrame: from baseline to 6 months
measure: Change of serum biomarkers of brain injury
timeFrame: from baseline to 6 months
measure: Total time spent on the intensive care unit
timeFrame: from baseline to hospital discharge (approx. 1 month)
measure: Total time spent in intubation
timeFrame: from baseline to hospital discharge (approx. 1 month)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neurology, University Hospital Basel
city: Basel
country: Switzerland
facility: Department of Neurosurgery, University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jehuda Soleman, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: