Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage

NCT ID: NCT04805177

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-08
• Study Completion Date: 2024-07-31

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.

Conditions

Intracerebral Hemorrhage (ICH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hematoma evacuation

Early minimally invasive image guided hematoma evacuation

Group Type: EXPERIMENTAL

hematoma evacuation

Intervention Type: PROCEDURE

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

Interventions

hematoma evacuation

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Heart Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jehuda Soleman, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Department of Neurology, University Hospital Basel

Basel, , Switzerland

Department of Neurosurgery, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

Hallenberger TJ, Guzman R, Soleman J. Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it. Acta Neurochir (Wien). 2023 Jun;165(6):1597-1602. doi: 10.1007/s00701-022-05326-3. Epub 2022 Aug 5.

Reference Type: DERIVED

PMID: 35930078 (View on PubMed)

Other Identifiers

2021-00161, ko21Bonati

Identifier Type: -

Identifier Source: org_study_id