Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

Recruiting now · Not applicable

Conditions studied: Transcranial Ultrasound With Sonolucent Cranioplasty, TUSC

In brief

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.

Key facts

Study ID

NCT05538286

Run by

Icahn School of Medicine at Mount Sinai

People needed

25

Starts

2022-09-23

Expected to finish

2027-09-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai Health System — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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