Transcranial Doppler in Children With Hemoglobinopathies

NCT ID: NCT04798157

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-10-31

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.

Conditions

Hemoglobinopathies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Children with Hemoglobinopathies

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

Group Type: EXPERIMENTAL

transcranial doppler

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• children diagnosed with hemoglobinopathies

Exclusion Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Elbadry Mohamed

teaching assistant , faculty of medicine , Sohag university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed E. Mohamed, ass. teacher

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine Sohag university

Central Contacts

Mohamed E. Mohamed, ass. teacher

Role: CONTACT

mohammad.albadry2012@gmail.com

+201030826466

Other Identifiers

Soh-Med-21-03-04

Identifier Type: -

Identifier Source: org_study_id