ClinicalTrials.gg
RecruitingNCT06404645NIRS-DETECTUpdated May 8, 2024

A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma

An observational study in Intracranial Hemorrhages, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 6 months later.

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 31 studies in Intracranial Hemorrhages with a site in China — 16 open to participants now, 16 under way, none of them phase 3. Intracranial Hemorrhages · China.

Started
2024
with 3 others
Observational
9 of 31
6 open now
Primary completion
2024-07
later than 1 of 15 live
Registered
20th of 31
by date

Among the 31 studies in Intracranial Hemorrhages with a site in China, this one is one of 4 that started in 2024, is one of 9 observational ones, reaches primary completion later than 1 of the 15 other live ones, and was the 20th registered.

Intracranial Hemorrhages

211 studies on the registry are indexed under Intracranial Hemorrhages; 62 are open to participants now.

Browse Intracranial Hemorrhages studies →

Open to participants now

16 of the 31 studies in Intracranial Hemorrhages with a site in China are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 43 Intracranial Hemorrhages studies recruiting now, 27 (63%) set no upper age limit and 5 (12%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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 subcranial hematoma.

03

Conditions studied

  • Intracranial Hemorrhages
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age above 18 years old
  2. Unilateral subcranial hemorrhage confirmed by cranial CT

Exclusion criteria

Exclusion Criteria:

  1. Bilateral subcranial hemorrhage
  2. Intracranial pneumoperitoneum in the location of the hemorrhage on cranial CT
  3. Obvious skull fracture in the location of hemorrhage on cranial CT
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • DeviceNear-infrared spectroscopy detection

    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.

06

What researchers measure

Primary outcomes

  1. NIRS data1

    NIRS data of bleeding side and the opposite side

    Time frame: 3 months

Secondary outcomes

  1. NIRS data2

    relationship between NIRS data and thickness of haematoma

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Jul 2024, 2 months after the start.

Of 44 non-industry observational studies under Intracranial Hemorrhages, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 130. This study's planned 2 months is below that.

Counting every sponsor, half of 49 studies reached it within 59 months; a quarter within 21 and three quarters within 105.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2024
First posted
May 8, 2024
StartActual
May 1, 2024
Primary completionEst.
Jul 31, 2024
CompletionEst.
Dec 31, 2024
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06404645
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
May 8, 2024
Start date
May 1, 2024
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 8, 2024

Study contacts

Ru Gong
Contact
gongru1987@126.com
13512193229
Junfeng Feng
study chair · RenJi Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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