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

NCT05151978 | Unknown DMC FDA Device

• 1 other identifier: 33574/12/19
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trauma, Brain

Keywords

Trans , cranial, TBI

Outcome Measures

Primary Outcomes (1)

• Secondary Neurological deterioration

  Decrease in glasgow coma scale and /or deterioration need to surgical intervention

  7 days

Study Arms (2)

(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

Transcranial Doppler DIAGNOSTIC_TEST

Transcranial Doppler on middle cerebral arteries

Also known as: CT of the brain

(glasgow coma scale) 9 _15; (glasgow coma scale) 9_15

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient with TBI

You may qualify if:

• patient with traumatic brain injury and glasgow coma scale 9\_15

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine

Tanta, 3511, Egypt

RECRUITING

Related Links

• https://pubmed.ncbi.nlm.nih.gov/31497078/

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Ahmed Goneim

  Head of faculty of medicine

  STUDY CHAIR

Central Study Contacts

Ahmed Abdelhafez

CONTACT

02040547758; Ahmed.abdelhafez@med.tanta.edu.eg

Mohamed Afandy

CONTACT

02040657855; Mohamed.afandy@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tanta elnady street elgharbia

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: June 3, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 22, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From October 2021 till December 2022
• Access Criteria: All data collected after statistical analysis

Locations

EG (1)