Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

Not Applicable

Recruiting

• Conditions: Transcranial Ultrasound With Sonolucent Cranioplasty; TUSC
• Interventions: Device: ClearFit implant; Procedure: transcranial ultrasonography through sonolucent cranioplasty

• Registration Number: NCT05538286
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Intracerebral hemorrhage (ICH) accounts for over 2 million strokes annually. ICH is the most devastating subtype of stroke, with a 1-year mortality rate of up to 50% and a 6-month survivor disability rate of up to 88%. Large-scale multicenter trials including STICH, STICH II, and MISTIE III demonstrated that surgical evacuation did not appear to improve long term functional outcome. Smaller studies and sub-group analyses have suggested that some forms of minimally invasive ICH evacuation may benefit specific patients. Postoperative rebleeding after surgical evacuation of ICH occurs in 5-40% and remains a major limitation to the efficacy and widespread adoption of this treatment strategy. Therefore, rapid assessment, detection, and management of postoperative bleeding is critical to maximize functional recovery after surgical evacuation.

The standard of care for postoperative hematoma cavity monitoring is computed tomography (CT). However, repeat CTs to assess patients with ICH incur health and financial cost including time and personnel to bring the patient to scan, risk of dislodging lines or drains, radiation dosing, and financial cost as well as others. 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.

In this prospective study, postoperative ICH patients will undergo cranioplasty with a sonolucent polymethyl methacrylate implant and serial monitoring via TUSC. Whenever a CT is performed during business hours, TUSC will be performed within 2 hours by a neurointensivist trained in point-of-care transcranial ultrasound (TCUS). Imaging will be reviewed by two independent neuroimaging experts. Additional secondary outcomes will include occurrence of serious adverse events, detection of intraventricular hemorrhage, and cost of care when compared to CT.

This work has the potential to significantly improve clinical management of ICH. This study will provide the safety and feasibility data necessary to guide future clinical research. ICH detection and volumetry are critical to patient care and prognostication. This point-of-care testing enables neurosurgeons to serially monitor patients to ensure that they receive timely, appropriate care.

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-13
• Study Start: 2022-09-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transcranial ultrasonography through sonolucent cranioplasty	transcranial ultrasonography through sonolucent cranioplasty	All surgical procedures and implants in this protocol are standard of care.
transcranial ultrasonography through sonolucent cranioplasty	ClearFit implant	All surgical procedures and implants in this protocol are standard of care.

Primary Outcome Measures

Name	Time	Method
The presence of intracerebral hemorrhage	at 6 months	Accuracy of TUSC via ClearFit to detect the presence or absence of postoperative intracerebral hemorrhage compared to CT.

Secondary Outcome Measures

Name	Time	Method
Accuracy of TUSC to detect intraventricular hemorrhage	at 6 months	Accuracy of TUSC to detect intraventricular hemorrhage compared to CT. Detection of intraventricular hemorrhage will be a categorical variable \[present, absent\].
TUSC/CT ratio for midline shift	at 6 months	TUSC/CT ratio to measure midline shift
Cost of TUSC	at 6 months	Cost of TUSC versus standard of care imaging (CT or MRI)
Accuracy of TUSC to detect hydrocephalus	at 6 months	Detection of hydrocephalus will be a categorical variable based on ventricle morphology and size \[present, absent\]
Serious Adverse Events related to ClearFit or TUSC	at 6 months	Serious Adverse Events related to ClearFit or TUSC
TUSC/CT ratio for distance between lateral ventricle frontal horns	at 6 months	TUSC/CT ratio to measure distance between lateral ventricle frontal horns.
Reimbursement rates for TUSC	at 6 months	Reimbursement rates for TUSC as a point of care examination in the ICU and outpatient clinic

Trial Locations

Locations (1)

Mount Sinai Health System; 🇺🇸 New York, New York, United States