Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
Icahn School of Medicine at Mount Sinai
25 participants
Sep 23, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05538286