Transcranial Doppler in Children With Hemoglobinopathies

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04798157

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemoglobinopathies	Radiation: transcranial doppler	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Role of Transcranial Doppler (TCD) in Children With Hemoglobinopathies

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Children with Hemoglobinopathies children from 2-18 years old , diagnosed to have hemoglobinopathy disease	Radiation: transcranial doppler 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.

Arm

Intervention/Treatment

Experimental: Children with Hemoglobinopathies

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

Radiation: transcranial doppler

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.

Outcome Measures

Primary Outcome Measures

Changes in the blood flow velocities at the circle of Willis [At procedure exam time]
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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children diagnosed with hemoglobinopathies

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

Principal Investigator: Mohamed E. Mohamed, ass. teacher, Faculty of medicine Sohag university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Ahmed Elbadry Mohamed, teaching assistant , faculty of medicine , Sohag university, Sohag University

ClinicalTrials.gov Identifier:

NCT04798157

Other Study ID Numbers:

Soh-Med-21-03-04

First Posted:

Mar 15, 2021

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemoglobinopathies

Study Results

No Results Posted as of Mar 15, 2021