NCT07107997

Brief Summary

The goal of this clinical trial is to assess the role of transcranial Doppler (TCD) in evaluating brain edema in traumatic brain injury. The main question it aims to answer is: Is TCD equivalent to brain computerized tomography (CT) in evaluating traumatic brain edema? Participants will be examined by both methods at the same time to assess the correlation between them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 12, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 31, 2025

Last Update Submit

August 7, 2025

Conditions

Traumatic Brain Injury

Keywords

Transcranial DopplerTraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • correlation between transcranial Doppler and brain CT in assessment of brain edema

    72 hours

Study Arms (1)

Traumatic brain injury patients

Traumatic brain injury patients, with brain edema

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients admitted to Critical Care Medicine Department in Alexandria University Hospitals

You may qualify if:

  • Patients with brain edema following traumatic brain injury, admitted within 24 hours

You may not qualify if:

  • Patients presented by out of hospital cardiac arrest or in-hospital cardiac arrest before performing the transcranial Doppler.
  • Pregnant females.
  • Inability to obtain adequate ultrasound window.
  • Temporal bone fracture or brain herniation.
  • Open head injuries or patients in need for surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Other (Specify), Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 6, 2025

Study Start

October 13, 2024

Primary Completion

April 13, 2025

Study Completion

June 13, 2025

Last Updated

August 12, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)