Sickle Cell DiseaseNCT02090881
Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease
A study testing Ultrasound scan in people with Sickle Cell Disease, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Ultrasound scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: Comparison of a Portable and Non-Portable Ultrasound Machine in the Evaluation of Children With Sickle Cell Disease - A Pilot Study
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.
Read more
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.
Read the detailed description
Please see above
- Conditions
- Sickle Cell Disease
- Being tested
- Ultrasound scan
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanOther
Trans cranial Doppler ultrasound examination of cerebral arterial blood flow
| Study group | Role | What they receive |
|---|---|---|
| ultrasound scan in ages 2-16 years | Experimental | 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. Receives: Other: Ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Mohammed Aslam, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090881
- Sponsor's protocol ID
- 13HH0858
- Status last verified
- Sep 2022
- First submitted
- 31 Oct 2013
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Portable and Non-Portable Ultrasound Machine in the Evaluation of Children With Sickle Cell Disease - A Pilot Study
- ClinicalTrials.gov ID
- NCT02090881
- Acronym / sponsor ID
- 13HH0858
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound scan in ages 2-16 years | Experimental | Other: Ultrasound scanChildren aged 2-16 years of age with Sickle Cell Disease and under the care of consultant haematologist as part of the NHS screening programme. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound scanTrans cranial Doppler ultrasound examination of cerebral arterial blood flow | Other | ultrasound scan in ages 2-16 years |
Primary outcome
Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines.
Time frame: 4 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Aslam principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound scan in people with Sickle Cell Disease, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Time Average Mean of the Maximum (TAMM) in cm/Sec in Cerebral Arteries Using 2 Different Ultrasound Machines. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.