Intracranial HematomaNCT02149082
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children
An observational study of Intracranial Hematoma, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intracranial Hematoma
- What is being tested?
- Infrascanner Model 2000
- Type of treatment
- Medical device
- How many people
- 465 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Emergency Department (ED), Pediatric Intensive Care Unit (PICU)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
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.
- Conditions
- Intracranial Hematoma
- Being tested
- Infrascanner Model 2000
- Keywords
- Intracranial hematoma, traumatic brain injury, Near infrared spectroscopy, NIRS
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrascanner Model 2000Device
The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Infrascanner exam | Infrascanner Model 2000 exams may be conducted either before or after an associated head CT for pediatric patients presenting to the emergency department (ED) or pediatric intensive care unit (PICU) with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence or absence of an intracranial hematoma. The time between the head CT scan and the Infrascanner exam will be within 6 hours. The exam involves placing a sensor on the designated areas of the head with the most common locations for traumatic hematoma. Readings from the monitor evaluating each region will be evaluated and recorded. The 8-point exam can be accomplished within 5 minutes or less. Receives: Device: Infrascanner Model 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of NIRS Optical Density (OD) Measurement
Determine the sensitivity of the NIRS optical density measurement by the Infrascanner device for identifying the presence of intracranial hematomas in pediatric patients after known or suspected traumatic brain injury compared to head CT scans as the gold standard
Measured: 2-years
Secondary outcomes (3)
Specificity and Predictive Values of NIRS Measurement
Determine the specificity, as well as positive and negative predictive values of the NIRS measurement for detecting intracranial hematomas
Measured: 2-years
Variability in Sensitivity and Specificity Based on Hematoma Characteristics
Determine whether sensitivity and specificity vary depending on hematoma type (i.e. epidural, subdural, subarachnoid, intracerebral), hematoma volume, distance of hematoma from brain surface, and skull thickness
Measured: 2-years
Age Varying Sensitivity
Determine whether the sensitivity of the NIRS measurement differs by patient age.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HematomaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Matthew Kirschen, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149082
- Sponsor's protocol ID
- 14-010812
- Status last verified
- Nov 2018
- First submitted
- 20 May 2014
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children
- ClinicalTrials.gov ID
- NCT02149082
- Acronym / sponsor ID
- 14-010812
- Conditions
- Intracranial Hematoma
- Keywords
- Intracranial hematoma, traumatic brain injury, Near infrared spectroscopy, NIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Children's Hospital Colorado
- Study start
- Jun 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infrascanner exam | – | Device: Infrascanner Model 2000Infrascanner Model 2000 exams may be conducted either before or after an associated head CT for pediatric patients presenting to the emergency department (ED) or pediatric intensive care unit (PICU) with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence or absence of an intracranial hematoma. The time between the head CT scan and the Infrascanner exam will be within 6 hours. The exam involves placing a sensor on the designated areas of the head with the most common locations for traumatic hematoma. Readings from the monitor evaluating each region will be evaluated and recorded. The 8-point exam can be accomplished within 5 minutes or less. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Emergency Department (ED), Pediatric Intensive Care Unit (PICU)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrascanner Model 2000The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding. | Device | Infrascanner exam |
Primary outcome
Sensitivity of NIRS Optical Density (OD) Measurement
Time frame: 2-years
Determine the sensitivity of the NIRS optical density measurement by the Infrascanner device for identifying the presence of intracranial hematomas in pediatric patients after known or suspected traumatic brain injury compared to head CT scans as the gold standard
3 secondary outcomes
Specificity and Predictive Values of NIRS Measurement
Time frame: 2-years
Variability in Sensitivity and Specificity Based on Hematoma Characteristics
Time frame: 2-years
Age Varying Sensitivity
Time frame: 2-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Kirschen, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hematoma, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of NIRS Optical Density (OD) Measurement (time frame: 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.