RECRUITING

Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

Conditions

Transcranial Ultrasound With Sonolucent Cranioplasty TUSC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation

Quick Facts

Study Start:2022-09-23

Study Completion:2024-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05538286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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

Inclusion Criteria

Exclusion 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 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

Contacts and Locations

Study Contact

Christopher P. Kellner, MD

CONTACT

(212) 241-6500

christopher.kellner@mountsinai.org

Christina P. Rossitto, BS

CONTACT

716-790-0204

christina.rossitto@icahn.mssm.edu

Principal Investigator

Christopher P. Kellner, MD

PRINCIPAL_INVESTIGATOR

Mount Sinai Health System Department of Neurosurgery

Study Locations (Sites)

Mount Sinai Health System

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Christopher P. Kellner, MD, PRINCIPAL_INVESTIGATOR, Mount Sinai Health System Department of Neurosurgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-23

Study Completion Date2024-09

Study Record Updates

Study Start Date2022-09-23

Study Completion Date2024-09

Terms related to this study

Additional Relevant MeSH Terms

Transcranial Ultrasound With Sonolucent Cranioplasty
TUSC