Within 12 Hrs of Head InjuryNCT02222597
An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.
An observational study of Within 12 Hrs of Head Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Within 12 Hrs of Head Injury
- What is being tested?
- infrascanner
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients within 12 hours after head injury visit the Emergency Department of the NTUH.
Who may be able to join
- The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled.
Who cannot join
- The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded.
- Patients with massive scalp laceration or hematoma were excluded. -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Emergency Department
Taipei, Taiwan
Meng-che Wu, MD, +886-972653208, mengcher111@gmail.com
About this study
The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients
- Conditions
- Within 12 Hrs of Head Injury
- Being tested
- infrascanner
- Keywords
- head injury, infrascanner, intracranial hemorrhage
- Medical subject headings
- Craniocerebral Trauma, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrascannerDevice
| Study group | Role | What they receive |
|---|---|---|
| positive infrascanner finding | Not described Receives: Device: infrascanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect the predictive value of the infrascanner for intracranial hemorrhage
Measured: within 12 hours after head injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Within 12 Hrs of Head InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222597
- Sponsor's protocol ID
- 201209046DPB
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.
- ClinicalTrials.gov ID
- NCT02222597
- Acronym / sponsor ID
- 201209046DPB
- Conditions
- Within 12 Hrs of Head Injury
- Keywords
- head injury, infrascanner, intracranial hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 21 Aug 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.
The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| positive infrascanner finding | – | Device: infrascanner |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients within 12 hours after head injury visit the Emergency Department of the NTUH.
Key inclusion criteria (1 listed)
- The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled.
Key exclusion criteria (2 listed)
- The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded.
- Patients with massive scalp laceration or hematoma were excluded. -
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 | Device | positive infrascanner finding |
Primary outcome
detect the predictive value of the infrascanner for intracranial hemorrhage
Time frame: within 12 hours after head injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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.
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 Within 12 Hrs of Head Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2014. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng-Che Wu, MD (+886-972653208, mengcher111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect the predictive value of the infrascanner for intracranial hemorrhage (time frame: within 12 hours after head injury). 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 26 Aug 2014.