Philadelphia, Pennsylvania 19104


Purpose:

This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density (OD) measurement with an Infrascanner device accurately identifies the presence of an intracranial hematoma in pediatric patients ≤18 years of age after known or suspected traumatic brain injury compared with head computerized tomography (CT) scans as the gold standard.


Study summary:

A key decision point in the management of patients with an acute traumatic brain injury is determining the presence of an intracranial hematoma that may require neurosurgical intervention. An expanding hematoma can lead to significant neurological morbidity or death due to brainstem compression or further ischemic injury. Unfortunately, no single physical sign, symptom, or score reliably indicates the presence of an intracranial hematoma. A computerized tomography (CT) scan of the head is the gold standard for emergent identification and localization of acute intracranial hematomas. However, the ionizing radiation from CT scans is associated with an increased risk of developing malignancies. Near infrared spectroscopy (NIRS) is a non-invasive technology that may be useful as an adjunctive modality to CT scanning for early identification of intracranial hematomas. A hand-held NIRS device called the Infrascanner has shown about 90% sensitivity and specificity for detecting intracranial hematomas in adults and a few small studies have shown similar results in children. The present study will aim to validate this device in a wide age range of pediatric subjects and in multiple hospital settings where this device may serve as a valuable screening tool.


Criteria:

Inclusion Criteria: - Males or females ≤18 years admitted to the Children's Hospital of Philadelphia (CHOP) ED or PICU with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence of an intracranial hematoma. - Head injury occurred <12 hours prior to presentation for the initial CT scan, or the subject had a clinical change prompting repeat CT scanning. Exclusion Criteria: - Evidence of extensive scalp injury including lacerations, avulsions, or abrasions that will impair proper coupling of the Infrascanner device to the subject's head or prevent placement of the device in the specified locations. - History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.


NCT ID:

NCT02149082


Primary Contact:

Principal Investigator
Matthew Kirschen, MD, PhD
Children's Hospital of Philadelphia

Matthew Kirschen, MD, PhD
Phone: 267-590-1719
Email: kirschenm@email.chop.edu


Backup Contact:

Email: woodforda1@email.chop.edu
Ashley Woodford
Phone: 267-426-7932


Location Contact:

Philadelphia, Pennsylvania 19104
United States

Ashley Woodford
Phone: 267-426-7932
Email: woodforda1@email.chop.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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