TUSC MIS: Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Recruiting
CT.gov ID
NCT05538286
Collaborator
(none)
25
1
1
24
1

Study Details

Study Description

Brief Summary

Postoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires significant physical and financial costs. Studies have demonstrated varying degrees of efficacy when using transcranial ultrasound to measure ICH volume. Recently, synthetic implants for cranioplasty have been shown to be safe and sonolucent. This study aims to evaluate the ability of transcranial ultrasound with sonolucent cranioplasty (TUSC) to detect and quantify bleeding in postoperative ICH patients.

Condition or Disease Intervention/Treatment Phase
  • Device: ClearFit implant
  • Procedure: transcranial ultrasonography through sonolucent cranioplasty
N/A

Detailed Description

Intracerebral hemorrhage (ICH) accounts for over 2 million strokes annually. ICH is the most devastating subtype of stroke, with a 1-year mortality rate of up to 50% and a 6-month survivor disability rate of up to 88%. Large-scale multicenter trials including STICH, STICH II, and MISTIE III demonstrated that surgical evacuation did not appear to improve long term functional outcome. Smaller studies and sub-group analyses have suggested that some forms of minimally invasive ICH evacuation may benefit specific patients. Postoperative rebleeding after surgical evacuation of ICH occurs in 5-40% and remains a major limitation to the efficacy and widespread adoption of this treatment strategy. Therefore, rapid assessment, detection, and management of postoperative bleeding is critical to maximize functional recovery after surgical evacuation.

The standard of care for postoperative hematoma cavity monitoring is computed tomography (CT). However, repeat CTs to assess patients with ICH incur health and financial cost including time and personnel to bring the patient to scan, risk of dislodging lines or drains, radiation dosing, and financial cost as well as others. Studies have demonstrated varying degrees of efficacy when using transcranial ultrasound to measure ICH volume. Recently, synthetic implants for cranioplasty have been shown to be safe and sonolucent. This study aims to evaluate the ability of transcranial ultrasound with sonolucent cranioplasty (TUSC) to detect and quantify bleeding in postoperative ICH patients.

In this prospective study, postoperative ICH patients will undergo cranioplasty with a sonolucent polymethyl methacrylate implant and serial monitoring via TUSC. Whenever a CT is performed during business hours, TUSC will be performed within 2 hours by a neurointensivist trained in point-of-care transcranial ultrasound (TCUS). Imaging will be reviewed by two independent neuroimaging experts. Additional secondary outcomes will include occurrence of serious adverse events, detection of intraventricular hemorrhage, and cost of care when compared to CT.

This work has the potential to significantly improve clinical management of ICH. This study will provide the safety and feasibility data necessary to guide future clinical research. ICH detection and volumetry are critical to patient care and prognostication. This point-of-care testing enables neurosurgeons to serially monitor patients to ensure that they receive timely, appropriate care.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
Anticipated Study Start Date :
Sep 9, 2022
Anticipated Primary Completion Date :
Sep 9, 2024
Anticipated Study Completion Date :
Sep 9, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: transcranial ultrasonography through sonolucent cranioplasty

All surgical procedures and implants in this protocol are standard of care.

Device: ClearFit implant
The ClearFit implant is an FDA cleared implant in regular use in the United States. The ClearFit implant and other PMMA cranioplasty implants manufactured by Longeviti have been reported to be safe and effective as cranial implants that permit transcranial ultrasound to be performed. The PMMA cranioplasty implant (Longeviti Neuro Solutions, Hunt Valley, MD) is clear, sonolucent, and was recently shown to be safe and effective in transcranial ultrasonography for bypass patency assessment. The ClearFit cranioplasty being used in this study is industry standard of care.

Procedure: transcranial ultrasonography through sonolucent cranioplasty
The implantation of the ClearFit PMMA sonolucent implant permits TUSC to be performed at the bedside for patients in both the in-patient and outpatient settings. While the patient is an inpatient, the clinical or research teams will attempt to perform TUSC within 1 hour of neuroimaging if that neuroimaging is performed at a time when a trained ultrasound operator is present.
Other Names:
  • TUSC
  • Outcome Measures

    Primary Outcome Measures

    1. The volume of intracerebral hemorrhage [at 6 months]

      Accuracy of TUSC via ClearFit to quantify the volume of intracerebral hemorrhage after MIS ICH evacuation will be calculated using the ABC/2 method.

    Secondary Outcome Measures

    1. Serious Adverse Events related to ClearFit or TUSC [at 6 months]

      Serious Adverse Events related to ClearFit or TUSC

    2. Accuracy of TUSC to detect the presence or absence of postoperative intracerebral hemorrhage [at 6 months]

      Accuracy of TUSC to detect the presence or absence of postoperative intracerebral hemorrhage compared to CT. Rebleeding is defined as ≥ 5mL increase in hematoma volume between any two CT scans. Symptomatic rebleeding is defined as any rebleeding that resulted in an increase in NIHSS ≥ 4 points. Detection of rebleeding or symptomatic rebleeding will be a categorical variable [present, absent].

    3. Accuracy of TUSC to detect intraventricular hemorrhage [at 6 months]

      Accuracy of TUSC to detect intraventricular hemorrhage compared to CT. Detection of intraventricular hemorrhage will be a categorical variable [present, absent].

    4. Accuracy of TUSC to quantify intraventricular hemorrhage volume (IVH) [at 6 months]

      Accuracy of TUSC to quantify intraventricular hemorrhage volume compared to CT. Volume of IVH will be calculated using semi-automated threshold guided segmentation.

    5. Accuracy of TUSC to quantify the ipsilateral lateral ventricle volume [at 6 months]

      Accuracy of TUSC to quantify the ipsilateral lateral ventricle volume compared to the gold standard. Volume of the ipsilateral ventricle will be calculated using semi-automated threshold guided segmentation.

    6. Cost of TUSC [at 6 months]

      Cost of TUSC versus standard of care imaging (CT or MRI)

    7. Reimbursement rates for TUSC [at 6 months]

      Reimbursement rates for TUSC as a point of care examination in the ICU and outpatient clinic

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Presence of spontaneous supratentorial ICH ≥20 mL

    • Age ≥18 years

    • National Institute of Health Stroke Scale (NIHSS) score ≥6

    • Undergoing minimally invasive intracerebral hemorrhage evacuation with sonolucent cranioplasty

    Individuals who meet enrolment in TUSC-MIS must also meet criteria for undergoing MIS ICH evacuation.

    Exclusion criteria:
    • Secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic infarct; or venous infarct

    • History of osteomyelitis

    • History of skull neoplasm

    • History of comminuted skull fractures

    • Infratentorial hemorrhage

    • Midbrain extension/involvement

    • Coagulopathy defined as INR > 1.4, elevated aPTT, or concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset; known hereditary or acquired hemorrhagic diathesis; coagulation factor deficiency; platelet count < 100x103cells/mm3, or known platelet dysfunction

    • GCS score < 7 at presentation

    • Inability to obtain consent from patient or appropriate surrogate (for patients without capacity)

    • Evidence of active infection indicated by fever ≥ 100.7F and/or open draining wound at the time of enrolment

    • Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 1 year

    • Based on investigator's judgment, the patient does not have the necessary mental capacity to participate or is unwilling to comply with the protocol follow-up appointment schedule

    • Active drug or alcohol abuse that, in the opinion of the site investigator, would interfere with adherence to study enrolments

    • Pre-existing DNR/DNI status

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Health System New York New York United States 10029

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Principal Investigator: Christopher P. Kellner, MD, Mount Sinai Health System Department of Neurosurgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Christopher P Kellner, Associate Professor, Department of Neurosurgery, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT05538286
    Other Study ID Numbers:
    • STUDY-21-01878
    First Posted:
    Sep 13, 2022
    Last Update Posted:
    Sep 13, 2022
    Last Verified:
    Sep 7, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 13, 2022