Intracranial HemorrhagesNIRS-DETECTNCT06404645
A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma
An observational study of Intracranial Hemorrhages, run by RenJi Hospital at 1 site in China.
Trial summary
This trial is a clinical prospective observational study. Cases meeting the entry criteria undergo near-infrared spectroscopy(NIRS）detection. Data collection mainly includes hematoma thickness on cranial CT, and bilateral NIRS data.This trial tries to explore the reliability and accuracy of NIRS detection of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- Near-infrared spectroscopy detection
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergo cranial CT that reveal a unilateral intracranial hemorrhage. Once meeting the inclusion and exclusion criteria, patients sign an informed consent and then undergo NIRS test.
Who may be able to join
- Age above 18 years old
- Unilateral subcranial hemorrhage confirmed by cranial CT
Who cannot join
- Bilateral subcranial hemorrhage
- Intracranial pneumoperitoneum in the location of the hemorrhage on cranial CT
- Obvious skull fracture in the location of hemorrhage on cranial CT
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201114
Junfeng Feng, +8613611860825, fengjfmail@163.com
About this study
This trial is a clinical prospective observational study. Cases meeting the entry criteria undergo near-infrared spectroscopy(NIRS）detection. Data collection mainly includes hematoma thickness on cranial CT, and bilateral NIRS data.This trial tries to explore the reliability and accuracy of NIRS detection of subcranial hematoma.
- Conditions
- Intracranial Hemorrhages
- Being tested
- Near-infrared spectroscopy detection
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopy detectionDevice
Cranial CT confirm intracranial haematoma. Then the near-infrared spectroscopy device to collect date by red sensor probe in the corresponding position on the scalp and blue sensor probe on the opposite side of the hematoma. Collect data for 10 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS data1
NIRS data of bleeding side and the opposite side
Measured: 3 months
Secondary outcomes (1)
NIRS data2
relationship between NIRS data and thickness of haematoma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 May 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junfeng Feng, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404645
- Sponsor's protocol ID
- LY2024-054-B
- Acronym
- NIRS-DETECT
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma
- ClinicalTrials.gov ID
- NCT06404645
- Acronym / sponsor ID
- NIRS-DETECT / LY2024-054-B
- Conditions
- Intracranial Hemorrhages
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 May 2024 (actual)
- 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 trial is a clinical prospective observational study. Cases meeting the entry criteria undergo near-infrared spectroscopy(NIRS）detection. Data collection mainly includes hematoma thickness on cranial CT, and bilateral NIRS data.This trial tries to explore the reliability and accuracy of NIRS detection of subcranial hematoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergo cranial CT that reveal a unilateral intracranial hemorrhage. Once meeting the inclusion and exclusion criteria, patients sign an informed consent and then undergo NIRS test.
Key inclusion criteria (2 listed)
- Age above 18 years old
- Unilateral subcranial hemorrhage confirmed by cranial CT
Key exclusion criteria (3 listed)
- Bilateral subcranial hemorrhage
- Intracranial pneumoperitoneum in the location of the hemorrhage on cranial CT
- Obvious skull fracture in the location of hemorrhage on cranial CT
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 |
|---|---|---|
| Near-infrared spectroscopy detectionCranial CT confirm intracranial haematoma. Then the near-infrared spectroscopy device to collect date by red sensor probe in the corresponding position on the scalp and blue sensor probe on the opposite side of the hematoma. Collect data for 10 minutes. | Device | – |
Primary outcome
NIRS data1
Time frame: 3 months
NIRS data of bleeding side and the opposite side
1 secondary outcome
NIRS data2
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Junfeng Feng study chair
RenJi Hospital
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 Hemorrhages, run by RenJi Hospital at 1 site in China.
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 3 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 8 May 2024. 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 China. 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 Ru Gong (13512193229, gongru1987@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIRS data1 (time frame: 3 months). 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 8 May 2024.