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NCT06404645 Clinical Trial

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

Intracranial Hemorrhages Clinical Trial

— NIRS-DETECT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06404645
Other study ID # LY2024-054-B
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source RenJi Hospital
Contact Ru Gong
Phone 13512193229
Email gongru1987@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 subcranial hematoma.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
China Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary NIRS data1 NIRS data of bleeding side and the opposite side 3 months
Secondary NIRS data2 relationship between NIRS data and thickness of haematoma 3 months
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