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New treatment option for Transcranial Ultrasound With Sonolucent Cranioplasty
Official title Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
ClinicalTrials.gov ID: NCT05538286
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm...
- History of osteomyelitis
- History of skull neoplasm
- History of comminuted skull fractures
- Infratentorial hemorrhage
- Midbrain extension/involvement
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.