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

March 28, 2023 updated by: Christopher P Kellner, Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Presence of spontaneous supratentorial ICH ≥20 mL
  • Age ≥18 years
  • National Institute of Health Stroke Scale (NIHSS) score ≥6
  • GCS score 5-15 at presentation
  • Undergoing minimally invasive intracerebral hemorrhage evacuation with sonolucent cranioplasty or hemicraniectomy with sonolucent cranioplasty

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of intracerebral hemorrhage
Time Frame: at 6 months
Accuracy of TUSC via ClearFit to detect the presence or absence of postoperative intracerebral hemorrhage compared to CT.
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events related to ClearFit or TUSC
Time Frame: at 6 months
Serious Adverse Events related to ClearFit or TUSC
at 6 months
Accuracy of TUSC to detect intraventricular hemorrhage
Time Frame: at 6 months
Accuracy of TUSC to detect intraventricular hemorrhage compared to CT. Detection of intraventricular hemorrhage will be a categorical variable [present, absent].
at 6 months
Cost of TUSC
Time Frame: at 6 months
Cost of TUSC versus standard of care imaging (CT or MRI)
at 6 months
Reimbursement rates for TUSC
Time Frame: at 6 months
Reimbursement rates for TUSC as a point of care examination in the ICU and outpatient clinic
at 6 months
TUSC/CT ratio for distance between lateral ventricle frontal horns
Time Frame: at 6 months
TUSC/CT ratio to measure distance between lateral ventricle frontal horns.
at 6 months
TUSC/CT ratio for midline shift
Time Frame: at 6 months
TUSC/CT ratio to measure midline shift
at 6 months
Accuracy of TUSC to detect hydrocephalus
Time Frame: at 6 months
Detection of hydrocephalus will be a categorical variable based on ventricle morphology and size [present, absent]
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2022

Primary Completion (Anticipated)

September 9, 2024

Study Completion (Anticipated)

September 9, 2024

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-21-01878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to minimize any privacy risks to the patients participating, IPD data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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