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Transcranial Doppler in Children With Hemoglobinopathies

Primary Purpose

Hemoglobinopathies

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial doppler
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hemoglobinopathies

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children diagnosed with hemoglobinopathies

Exclusion Criteria:

  • Children before two years old .
  • Hemoglobinopathy patients more than 18 years .
  • Uncooperative patients .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Children with Hemoglobinopathies

    Arm Description

    children from 2-18 years old , diagnosed to have hemoglobinopathy disease

    Outcomes

    Primary Outcome Measures

    Changes in the blood flow velocities at the circle of Willis
    The children will be be subjected to Transcranial Doppler (TCD ) , and velocity indices will be obtained , the subjects will be classified according the TAMMV (time average mean maximum velocities ) into high risk group with TAMMV > 200 cm/sec , and normal group <170 cm/sec , and conditional group with TAMMV 170-200 cm/sec .

    Secondary Outcome Measures

    Full Information

    First Posted
    March 11, 2021
    Last Updated
    March 12, 2021
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04798157
    Brief Title
    Transcranial Doppler in Children With Hemoglobinopathies
    Official Title
    Role of Transcranial Doppler (TCD) in Children With Hemoglobinopathies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    October 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Transcranial Doppler ultrasonography (TCD) is a noninvasive, portable technique for evaluating the intracranial vasculature. TCD ultrasonography is performed placing a low frequency (≤ 2 MHz) transducer on the scalp of the patient, in order to visualize the intracranial arterial vessels through specific acoustic windows, where bone is thinner, and evaluate cerebral blood flow velocity (CBFV) . Patients diagnosed to have hemoglobinopathy conditions with its most common forms thalassemia and sickle cell disease manifest both biochemical and clinical evidence of hypercoagulability conditions include deep venous thrombosis, pulmonary emboli and recurrent arterial occlusion . Cerebrovascular accidents can be identified using transcranial Doppler ultrasonography which enables evaluation of cerebral artery blood flow velocity with a sensitivity of 90% and specificity of 100 % when compared with cerebral angiography . According to the stroke prevention trial in sickle cell anemia (STOP) study ,TCDs were classified based on blood velocity in the circle of Willis, expressed as time averaged mean of the maximum velocity (TAMMV). Children with abnormal, high velocities (>200cm/s) were at increased risk of stroke, which was reduced by 90% after starting regular blood transfusions. TAMMVs less than 170cm/s were classified as normal with annual TCD scanning recommended, whereas velocities between 170 and 200cm/s were called conditional, and followed up more closely without starting transfusion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemoglobinopathies

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Children with Hemoglobinopathies
    Arm Type
    Experimental
    Arm Description
    children from 2-18 years old , diagnosed to have hemoglobinopathy disease
    Intervention Type
    Radiation
    Intervention Name(s)
    transcranial doppler
    Intervention Description
    Transcranial Doppler ultrasonography will be done using the ultrasound machine by placing a transducer over the relatively thinner temporal and occipital bones in order to visualize and evaluate the velocities at the circle of Willis.
    Primary Outcome Measure Information:
    Title
    Changes in the blood flow velocities at the circle of Willis
    Description
    The children will be be subjected to Transcranial Doppler (TCD ) , and velocity indices will be obtained , the subjects will be classified according the TAMMV (time average mean maximum velocities ) into high risk group with TAMMV > 200 cm/sec , and normal group <170 cm/sec , and conditional group with TAMMV 170-200 cm/sec .
    Time Frame
    At procedure exam time

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children diagnosed with hemoglobinopathies Exclusion Criteria: Children before two years old . Hemoglobinopathy patients more than 18 years . Uncooperative patients .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed E. Mohamed, ass. teacher
    Phone
    +201030826466
    Email
    mohammad.albadry2012@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed E. Mohamed, ass. teacher
    Organizational Affiliation
    Faculty of medicine Sohag university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Transcranial Doppler in Children With Hemoglobinopathies

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