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

NCT06404645 | Recruiting

• 1 other identifier: LY2024-054-B
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Hemorrhages

Outcome Measures

Primary Outcomes (1)

• NIRS data1

  NIRS data of bleeding side and the opposite side

  3 months

Secondary Outcomes (1)

• NIRS data2

  3 months

Interventions

Near-infrared spectroscopy detection DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age above 18 years old
• Unilateral subcranial hemorrhage confirmed by cranial CT

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201114, China

RECRUITING

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junfeng Feng

  RenJi Hospital

  STUDY CHAIR

Central Study Contacts

Ru Gong

CONTACT

13512193229; gongru1987@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)