A Clinical Prospective Observational Study of Near Infrar... | NCT06404645

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

NCT06404645

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

May 8, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Intracranial Hemorrhages

Interventions

Near-infrared spectroscopy detection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

May 5, 2024

First Submission Date that Met QC Criteria

May 5, 2024

First Posted Date

May 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2024

Last Update Posted Date

May 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NIRS data1	NIRS data of bleeding side and the opposite side	3 months

Secondary Outcomes

Measure	Description	Time Frame
NIRS data2	relationship between NIRS data and thickness of haematoma	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ru Gong	Contact	13512193229		gongru1987@126.com

Overall Officials

Name	Affiliation	Role
Junfeng Feng	RenJi Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Recruiting	Shanghai	Shanghai Municipality	201114	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020300	Intracranial Hemorrhages

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided