Actively Recruiting
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-05
25
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of spontaneous supratentorial intracerebral hemorrhage (ICH) 20 mL or larger
- Age 18 years or older
- National Institute of Health Stroke Scale (NIHSS) score of 6 or higher
- Glasgow Coma Scale (GCS) score between 5 and 15 at presentation
- Undergoing minimally invasive intracerebral hemorrhage evacuation with sonolucent cranioplasty or hemicraniectomy with sonolucent cranioplasty
You will not qualify if you...
- Secondary causes for ICH such as vascular malformations, aneurysms, tumors, hemorrhagic transformation of ischemic stroke, or venous infarct
- History of osteomyelitis
- History of skull neoplasm
- History of comminuted skull fractures
- Infratentorial hemorrhage
- Midbrain extension or involvement
- Coagulopathy including INR > 1.4, elevated aPTT, use of direct oral anticoagulants or low molecular weight heparin at ICH onset, hemorrhagic diathesis, coagulation factor deficiency, platelet count below 100,000 cells/mm3, or platelet dysfunction
- Inability to obtain consent from patient or appropriate surrogate
- Active infection indicated by fever 100.7°F or higher and/or open draining wound at enrollment
- Any disease or condition expected to impair survival or ability to complete follow-up through 1 year
- Lack of mental capacity or unwillingness to comply with follow-up schedule
- Active drug or alcohol abuse interfering with study adherence
- Pre-existing do-not-resuscitate or do-not-intubate status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mount Sinai Health System
New York, New York, United States, 10029
Actively Recruiting
Research Team
C
Christopher P. Kellner, MD
CONTACT
S
Sydney Edwards
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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