Transcranial Doppler in Children With Hemoglobinopathies
Primary Purpose
Hemoglobinopathies
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial doppler
Sponsored by
About this trial
This is an interventional diagnostic trial for Hemoglobinopathies
Eligibility Criteria
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
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
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Transcranial Doppler in Children With Hemoglobinopathies
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