Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Sep 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new method called transcranial ultrasound with sonolucent cranioplasty (TUSC) to help doctors detect and measure bleeding in patients who have had surgery to remove blood from the brain due to a condition called intracerebral hemorrhage (ICH). The goal is to find out if this method can be a better and less costly way to monitor patients after surgery compared to traditional methods like CT scans, which can be expensive and require significant resources.

To be eligible for this trial, participants should be at least 18 years old and have a certain type of ICH that is large enough (20 mL or more). They should also be undergoing a specific type of surgery for this condition. Some people may not be eligible, such as those with certain complications or health issues that could affect their recovery. If someone joins the trial, they can expect to undergo the surgery and then have their bleeding monitored using the new ultrasound method, which may offer a more efficient way to keep track of their recovery.

Gender

ALL

Eligibility 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