Using ultrasound with special cranioplasty to monitor bleeding after brain surgery
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
This study is testing if using ultrasound with a special type of skull implant can help doctors quickly find and measure bleeding after brain surgery for patients with brain hemorrhages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05538286 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcranial ultrasound combined with sonolucent cranioplasty to detect and quantify postoperative bleeding in patients who have undergone minimally invasive evacuation of intracerebral hemorrhage (ICH). The research aims to provide a less costly and less invasive alternative to traditional computed tomography (CT) scans for monitoring hematoma cavities. By utilizing synthetic implants that are safe and allow ultrasound penetration, the study seeks to improve patient outcomes by enabling rapid assessment of bleeding. The goal is to enhance recovery and reduce complications associated with ICH surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with spontaneous supratentorial ICH of 20 mL or more and a specific level of neurological impairment.
Not a fit: Patients with secondary causes of ICH, significant coagulopathy, or other specific medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for CT scans, lowering costs and risks for patients while improving monitoring of postoperative bleeding.
How similar studies have performed: While studies have shown varying degrees of success with transcranial ultrasound for ICH monitoring, this specific approach using sonolucent cranioplasty is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Mount Sinai Health System — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Christopher P. Kellner, MD — Mount Sinai Health System Department of Neurosurgery
- Study coordinator: Christopher P. Kellner, MD
- Email: christopher.kellner@mountsinai.org
- Phone: (212) 241-6500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.