Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Doppler in Children With Hemoglobinopathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04798157
Recruitment Status : Not yet recruiting
First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Elbadry Mohamed, Sohag University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in the blood flow velocities at the circle of Willis [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children diagnosed with hemoglobinopathies

Exclusion Criteria:

  • Children before two years old .
  • Hemoglobinopathy patients more than 18 years .
  • Uncooperative patients .
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798157


Contacts
Layout table for location contacts
Contact: Mohamed E. Mohamed, ass. teacher +201030826466 mohammad.albadry2012@gmail.com

Sponsors and Collaborators
Sohag University
Investigators
Layout table for investigator information
Principal Investigator: Mohamed E. Mohamed, ass. teacher Faculty of medicine Sohag university
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: March 15, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemoglobinopathies
Hematologic Diseases
Genetic Diseases, Inborn