Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease

NCT ID: NCT02090881

Last Updated: 2023-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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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

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Please see above

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ultrasound scan in ages 2-16 years

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.

Group Type EXPERIMENTAL

Ultrasound scan

Intervention Type OTHER

Trans cranial Doppler ultrasound examination of cerebral arterial blood flow

Interventions

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Ultrasound scan

Trans cranial Doppler ultrasound examination of cerebral arterial blood flow

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammed Aslam

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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13HH0858

Identifier Type: -

Identifier Source: org_study_id

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