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

November 26, 2021 updated by: Mai Kamal, Tanta University

Transcranial Doppler as an Early Predictor of Neurological Outcome in Mild and Moderate Traumatic Brain Injury

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Tanta, Egypt, 3511
        • Recruiting
        • Faculty of medicine
        • Contact:
          • aymen elghamry
        • Contact:
          • hala elgendy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with TBI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
(glasgow coma scale) 9 _15
No Secondary Neurological deterioration
Diagnostic test: Transcranial Doppler
Transcranial Doppler on middle cerebral arteries
Other Names:
  • CT of the brain
(glasgow coma scale) 9_15
Secondary Neurological deterioration
Diagnostic test: Transcranial Doppler
Transcranial Doppler on middle cerebral arteries
Other Names:
  • CT of the brain

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Chair: Ahmed Goneim, Head of faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2021

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

February 22, 2022

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

November 26, 2021

First Posted (ACTUAL)

December 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33574/12/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

From October 2021 till December 2022

IPD Sharing Access Criteria

All data collected after statistical analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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