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

NCT ID: NCT06404645

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Hemorrhages

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Near-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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junfeng Feng

Role: STUDY_CHAIR

RenJi Hospital

Locations

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Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ru Gong

Role: CONTACT

13512193229

Facility Contacts

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Junfeng Feng

Role: primary

+8613611860825

Other Identifiers

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LY2024-054-B

Identifier Type: -

Identifier Source: org_study_id

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