Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage

NCT04805177 | Completed

• 1 other identifier: 2021-00161, ko21Bonati
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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).

Conditions

Intracerebral Hemorrhage (ICH)

Keywords

endoscopic evacuation; pilot study; spontaneous supratentorial Intracerebral Hemorrhage (SSICH); minimally invasive image guided endoscopic surgery; early hematoma evacuation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in relative (percentage) hematoma volume

  from baseline to 24 hours after treatment

• Change of focal neurological deficit measured by the NIHSS

  from baseline to 6 months

• Change of serum biomarkers of brain injury

  from baseline to 6 months

• Total time spent on the intensive care unit

  from baseline to hospital discharge (approx. 1 month)

• Total time spent in intubation

  from baseline to hospital discharge (approx. 1 month)

Study Arms (1)

hematoma evacuation

EXPERIMENTAL

Early minimally invasive image guided hematoma evacuation

Procedure: hematoma evacuation

Interventions

hematoma evacuation PROCEDURE

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

hematoma evacuation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Heart Foundation: collaborator

Study Sites (2)

Department of Neurology, University Hospital Basel

Basel, 4031, Switzerland

Location

Department of Neurosurgery, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35930078 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jehuda Soleman, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single arm pilot study

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: August 8, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)