Transcranial Doppler in Children With Hemoglobinopathies

NCT04798157 | Unknown

• 1 other identifier: Soh-Med-21-03-04
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 .

  At procedure exam time

Study Arms (1)

Children with Hemoglobinopathies

EXPERIMENTAL

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

Radiation: transcranial doppler

Interventions

transcranial doppler 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.

Children with Hemoglobinopathies

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children diagnosed with hemoglobinopathies

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Hemoglobinopathies

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Mohamed E. Mohamed, ass. teacher

  Faculty of medicine Sohag university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed E. Mohamed, ass. teacher

CONTACT

+201030826466; mohammad.albadry2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant , faculty of medicine , Sohag university

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share