Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria:
- Clinical Diagnosis of Sickle Cell Disease
- Under surveillance as part of the NHS Sickle Cell & Thalassaemia Screening Programme
- Children between the ages of 2 - 16 years old. Those under 16 years of age must be accompanied by a responsible adult.
Exclusion Criteria:
- Participants older than 16 years of age as this is outside the scope of the sickle cell screening programme.
- Individuals unable to give fully informed and voluntary consent.
- Individuals with inadequate temporal windows as it will not be possible to record measurements of velocity.
Sites / Locations
- Imperial College Healthcare NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ultrasound scan in ages 2-16 years
Arm Description
Children aged 2-16 years of age with Sickle Cell Disease and under the care of consultant haematologist as part of the NHS screening programme.
Outcomes
Primary Outcome Measures
Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines.
A flow phantom was used to compare Time average mean maximum velocity measurements from a Philips IU-22 and Zonare Z-One ultrasound machine. 25 children with SCD (aged 2-15 years) attending the outpatient clinic at St. Mary's Hospital, Imperial College Healthcare NHS Trust as part of the NHS Sickle Cell & Thalassaemia (SC&T) screening programme, were studied. The Time Averaged Mean of the Maximum (TAMM) velocities in the middle cerebral artery (MCA) and stroke risk categorisation using the two ultrasound machines were compared.
Secondary Outcome Measures
Full Information
NCT ID
NCT02090881
First Posted
October 31, 2013
Last Updated
September 30, 2022
Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT02090881
Brief Title
Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease
Official Title
Comparison of a Portable and Non-Portable Ultrasound Machine in the Evaluation of Children With Sickle Cell Disease - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sickle cell disease (SCD) affects haemoglobin - the molecule in blood cells which carries oxygen. It causes red blood cells to become abnormal crescent (or sickle)- shaped. Sickled red blood cells cannot travel through small blood vessels as easily as normal red blood cells which can lead to blockages. This means that oxygen may be prevented from getting to where it is needed. Individuals with sickle cell disease also suffer form abnormality in the lining of their blood vessels, which contributes to the damage.
Damage and blockage can occur in the blood vessels in the brain and means that children with sickle cell disease have a significant risk of suffering from strokes. Research has shown that transcranial Doppler ultrasonography can be used in this setting to identify children at most risk of getting strokes.
Ultrasound is therefore used in children with sickle cell disease to measure the blood flow in the vessels in the brain. This research has formed the basis of the National Health Service (NHS) Standard of Care for Sickle Cell Disease in the United Kingdom (UK) which uses transcranial Doppler ultrasonography at once a year to screen children with sickle cell disease aged 2 to 16.
Ultrasound is used because it is portable, does not uses ionising radiation such as x-rays, is non-invasive and gives good results. However, the results are dependent on the operator. This means that the screening service is provided by centres of excellence with experienced scanning staff visiting clinics in smaller hospitals with portable machines. There is a lack of research comparing the use of portable machines to laboratory-based machines. This is important because screening can identify children at high risk of stroke and may be used by clinical staff to make a decision about the care of the child.
Detailed Description
Please see above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound scan in ages 2-16 years
Arm Type
Experimental
Arm Description
Children aged 2-16 years of age with Sickle Cell Disease and under the care of consultant haematologist as part of the NHS screening programme.
Intervention Type
Other
Intervention Name(s)
Ultrasound scan
Intervention Description
Trans cranial Doppler ultrasound examination of cerebral arterial blood flow
Primary Outcome Measure Information:
Title
Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines.
Description
A flow phantom was used to compare Time average mean maximum velocity measurements from a Philips IU-22 and Zonare Z-One ultrasound machine. 25 children with SCD (aged 2-15 years) attending the outpatient clinic at St. Mary's Hospital, Imperial College Healthcare NHS Trust as part of the NHS Sickle Cell & Thalassaemia (SC&T) screening programme, were studied. The Time Averaged Mean of the Maximum (TAMM) velocities in the middle cerebral artery (MCA) and stroke risk categorisation using the two ultrasound machines were compared.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical Diagnosis of Sickle Cell Disease
Under surveillance as part of the NHS Sickle Cell & Thalassaemia Screening Programme
Children between the ages of 2 - 16 years old. Those under 16 years of age must be accompanied by a responsible adult.
Exclusion Criteria:
Participants older than 16 years of age as this is outside the scope of the sickle cell screening programme.
Individuals unable to give fully informed and voluntary consent.
Individuals with inadequate temporal windows as it will not be possible to record measurements of velocity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Aslam
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease
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