Transcranial Doppler in Mild and Moderate Traumatic Brain... | NCT05151978

Studies
Transcranial Doppler in Mild and Moderate Traumatic Brain Injury (TBI)

NCT05151978

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Dec 9, 2021Actual

Enrollment

105Estimated

Phase

Not provided

Conditions

Trauma, Brain

Interventions

Transcranial Doppler

Countries

Egypt

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

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

Jun 3, 2021Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Feb 22, 2022Estimated

First Submitted Date

Nov 26, 2021

First Submission Date that Met QC Criteria

Nov 26, 2021

First Posted Date

Dec 9, 2021Actual

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

Nov 26, 2021

Last Update Posted Date

Dec 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

Utility of transcranial Doppler as an Early Predictor of Neurological deterioration in Mild and Moderate Traumatic Brain Injury

Detailed Description

Transcranial Doppler done to TBI patients on admission and follow up was done and Secondary Neurological deterioration was documented

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

105Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
(glasgow coma scale) 9 _15		No Secondary Neurological deterioration	Diagnostic Test: Transcranial Doppler
(glasgow coma scale) 9_15		Secondary Neurological deterioration	Diagnostic Test: Transcranial Doppler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Doppler	Diagnostic Test	Transcranial Doppler on middle cerebral arteries	(glasgow coma scale) 9 _15 (glasgow coma scale) 9_15

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Secondary Neurological deterioration	Decrease in glasgow coma scale and /or deterioration need to surgical intervention	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with traumatic brain injury and glasgow coma scale 9_15

Exclusion Criteria:

Unstable or patient on Mechanical ventilation, Sever brain injury , patient receive anticoagulant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patient with TBI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Abdelhafez	Contact	02040547758		Ahmed.abdelhafez@med.tanta.edu.eg
Mohamed Afandy	Contact	02040657855		Mohamed.afandy@med.tanta.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed Goneim	Head of faculty of medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine	Recruiting	Tanta		3511	Egypt

Label	URL
https://pubmed.ncbi.nlm.nih.gov/31497078/	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data of transcranial Doppler of middle cerebral arteries and the Neurological outcome

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

From October 2021 till December 2022

Access Criteria

All data collected after statistical analysis

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 30, 2021	Jun 3, 2021	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017585	Ultrasonography, Doppler, Transcranial

Ancestor Terms

ID	Term
D004453	Echoencephalography
D009485	Neuroradiography
D059906	Neuroimaging
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided