Blood DiseaseNCT06498726
Role of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia CNS.
An observational study of Blood Disease and Brain Injuries, run by Eman Abdul-Hai.
Trial summary
This study aimed to determine the Predictive Value of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia. Specific aims are: Demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Blood Disease, Brain Injuries
- What is being tested?
- transcranial doppler
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- Child, Adult
Study population: This prospective cross-sectional will include 18 patients who are diagnosed with sickle cell anemia of either sex aged 1 to 18 years old; free from neurological disorders ,at Assiut University pediatric Hospital.
Who may be able to join
- (1) age, from 24 months to 18 years; (2) hemoglobinopathy diagnosis of Hb SS; (3) the desire and ability to be screened as evidenced by signed parental informed consent and child's assent; (4) the availability for follow-up for at least 2 years.
Who cannot join
- 1.Other sickle cell syndromes were excluded because they had a lower or uncertain risk of stroke.
- 2.A child was excluded from TCD screening for any of the following: an indication for chronic blood transfusion or a contraindication to chronic transfusion, participation in any study involving treatments which might confound the interpretation of the results of the proposed work
Trial locations and contacts
No sites are listed yet.
About this study
This study aimed to determine the Predictive Value of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia.
Specific aims are:
Read more
Demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA in Pediatric Hematology unit at Assiut University Hospital
Detect any abnormality with vasculopathy, arterial occlusion and old SCI. Strokes in children with SCD can be prevented by checking a transcranial Doppler (TCD) ultrasound,MRA and providing blood transfusions to children with abnormal blood flow on the TCD and detect Silent cerebral and cerebrovascular changes in SCD.
Read the detailed description
Cerebro-vascular accident is a destructive complication of sickle cell disease, CVA is a important cause of morbidity and mortality individuals with SCD, which cause motor and neurocognitive complications. The CVA pathophysiology can be described by vasculopathy and obstruction caused by the sickle erythrocytes with narrowing of cerebral vessels of the circle of Willis (middle cerebral artery, anterior cerebral artery, anterior communicating artery, internal carotid artery, posterior cerebral artery, and posterior communicating artery).
Patients with sickle cell disease develop vasculopathy and obstruction at specific sites as distal internal carotid artery (ICA) and the proximal segments of the middle cerebral artery (MCA) and anterior cerebral artery (ACA). This Study have been concerned to identify synchronous risk factors for Cerebro-vascular accident and the presence of increase in cerebral blood flow velocity (CBFV) in arterial parts of the polygon of Willis by transcranial doppler (TCD) has been confirmed as the important risk factor for the development of ischemic Cerebrovascular accidents in children and adolescents with SCA. TCD can detect intracranial arterial narrowing caused by arterial vasculopathy associated with SCA. TCD is a non-invasive, portable, and relatively inexpensive method that uses specific areas of the skull to access the intracranial arterial circulation and to measure CBFV in the polygon of Willis arteries, magnetic resonance Angiography (MRA), and cerebral angiography are available for cerebrovascular disease diagnosis.(5-8) However, TCD is due to its operator dependent, it has a narrow application area. Cerebrovascular disease indicates a group of disorders that alter the flow of blood in the brain. The brain's functions can be temporarily or permanently impaired as a result of this change in blood flow. Timely diagnosis and treatment can restore the brain-impaired functions, resulting in a much-improved prognosis for the patients. This review summarizes the basic principles underlying the TCD imaging technique and its utility as a diagnostic tool for cerebrovascular disease.
- Conditions
- Blood Disease, Brain Injuries
- Being tested
- transcranial doppler
- Medical subject headings
- Hematologic Diseases, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial dopplerDevice
Also called MRA
Demographic and procedural variables will be extracted from medical record assistants , and analysis of recorded images TCD, MRA ,interpretation reports will be assessed , Completeness of protocol components will be assessed Data accuracy and protocol fidelity will be ensured through site monitoring
| Study group | Role | What they receive |
|---|---|---|
| 1 | This prospective cross-sectional will include 18 patients who are diagnosed with sickle cell anemia of either sex aged 1 to 18 years old; free from neurological disorders. Receives: Device: transcranial doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
silent parenchymal and vascular brain changes in Sickle cell disease.
the main outcome variable which is to demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA
Measured: TWO YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Abdul-Hai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Abdul-Hai, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498726
- Sponsor's protocol ID
- sickle cell anemia
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Deus-Silva L, Bonilha L, Damasceno BP, Costa AL, Yasuda CL, Costa FF, Santos AO, Etchebehere EC, Oquendo-Nogueira R, Fockink R, de Freitas CF, Camargo EE, Li LM, Cendes F, Saad ST. Brain Perfusion Impairment in Neurologically Asymptomatic Adult Patients with Sickle-Cell Disease Shown by Voxel-Based Analysis of SPECT Images. Front Neurol. 2013 Dec 20;4:207. doi: 10.3389/fneur.2013.00207. eCollection 2013.
PubMed 24391625Helton KJ, Adams RJ, Kesler KL, Lockhart A, Aygun B, Driscoll C, Heeney MM, Jackson SM, Krishnamurti L, Miller ST, Sarnaik SA, Schultz WH, Ware RE; SWiTCH Investigators. Magnetic resonance imaging/angiography and transcranial Doppler velocities in sickle cell anemia: results from the SWiTCH trial. Blood. 2014 Aug 7;124(6):891-8. doi: 10.1182/blood-2013-12-545186. Epub 2014 Jun 9.
PubMed 24914136
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia CNS.
- ClinicalTrials.gov ID
- NCT06498726
- Acronym / sponsor ID
- sickle cell anemia
- Conditions
- Blood Disease, Brain Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Eman Abdul-HaiUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the Predictive Value of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia.
Specific aims are:
Demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA in Pediatric Hematology unit at Assiut University Hospital
Detect any abnormality with vasculopathy, arterial occlusion and old SCI. Strokes in children with SCD can be prevented by checking a transcranial Doppler (TCD) ultrasound,MRA and providing blood transfusions to children with abnormal blood flow on the TCD and detect Silent cerebral and cerebrovascular changes in SCD.
Detailed description
Cerebro-vascular accident is a destructive complication of sickle cell disease, CVA is a important cause of morbidity and mortality individuals with SCD, which cause motor and neurocognitive complications. The CVA pathophysiology can be described by vasculopathy and obstruction caused by the sickle erythrocytes with narrowing of cerebral vessels of the circle of Willis (middle cerebral artery, anterior cerebral artery, anterior communicating artery, internal carotid artery, posterior cerebral artery, and posterior communicating artery).
Patients with sickle cell disease develop vasculopathy and obstruction at specific sites as distal internal carotid artery (ICA) and the proximal segments of the middle cerebral artery (MCA) and anterior cerebral artery (ACA). This Study have been concerned to identify synchronous risk factors for Cerebro-vascular accident and the presence of increase in cerebral blood flow velocity (CBFV) in arterial parts of the polygon of Willis by transcranial doppler (TCD) has been confirmed as the important risk factor for the development of ischemic Cerebrovascular accidents in children and adolescents with SCA. TCD can detect intracranial arterial narrowing caused by arterial vasculopathy associated with SCA. TCD is a non-invasive, portable, and relatively inexpensive method that uses specific areas of the skull to access the intracranial arterial circulation and to measure CBFV in the polygon of Willis arteries, magnetic resonance Angiography (MRA), and cerebral angiography are available for cerebrovascular disease diagnosis.(5-8) However, TCD is due to its operator dependent, it has a narrow application area. Cerebrovascular disease indicates a group of disorders that alter the flow of blood in the brain. The brain's functions can be temporarily or permanently impaired as a result of this change in blood flow. Timely diagnosis and treatment can restore the brain-impaired functions, resulting in a much-improved prognosis for the patients. This review summarizes the basic principles underlying the TCD imaging technique and its utility as a diagnostic tool for cerebrovascular disease.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: transcranial dopplerThis prospective cross-sectional will include 18 patients who are diagnosed with sickle cell anemia of either sex aged 1 to 18 years old; free from neurological disorders. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- This prospective cross-sectional will include 18 patients who are diagnosed with sickle cell anemia of either sex aged 1 to 18 years old; free from neurological disorders ,at Assiut University pediatric Hospital.
Key inclusion criteria (1 listed)
- (1) age, from 24 months to 18 years; (2) hemoglobinopathy diagnosis of Hb SS; (3) the desire and ability to be screened as evidenced by signed parental informed consent and child's assent; (4) the availability for follow-up for at least 2 years.
Key exclusion criteria (2 listed)
- 1.Other sickle cell syndromes were excluded because they had a lower or uncertain risk of stroke.
- 2.A child was excluded from TCD screening for any of the following: an indication for chronic blood transfusion or a contraindication to chronic transfusion, participation in any study involving treatments which might confound the interpretation of the results of the proposed work
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 |
|---|---|---|
| transcranial dopplerAlso: MRADemographic and procedural variables will be extracted from medical record assistants , and analysis of recorded images TCD, MRA ,interpretation reports will be assessed , Completeness of protocol components will be assessed Data accuracy and protocol fidelity will be ensured through site monitoring | Device | 1 |
Primary outcome
silent parenchymal and vascular brain changes in Sickle cell disease.
Time frame: TWO YEARS
the main outcome variable which is to demonstrate silent parenchymal and vascular brain changes that are incidentally observed in neurologically free SCD children using screening TCD and MRA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 24391625Deus-Silva L, Bonilha L, Damasceno BP, Costa AL, Yasuda CL, Costa FF, Santos AO, Etchebehere EC, Oquendo-Nogueira R, Fockink R, de Freitas CF, Camargo EE, Li LM, Cendes F, Saad ST. Brain Perfusion Impairment in Neurologically Asymptomatic Adult Patients with Sickle-Cell Disease Shown by Voxel-Based Analysis of SPECT Images. Front Neurol. 2013 Dec 20;4:207. doi: 10.3389/fneur.2013.00207. eCollection 2013.
- Background: PubMed 24914136Helton KJ, Adams RJ, Kesler KL, Lockhart A, Aygun B, Driscoll C, Heeney MM, Jackson SM, Krishnamurti L, Miller ST, Sarnaik SA, Schultz WH, Ware RE; SWiTCH Investigators. Magnetic resonance imaging/angiography and transcranial Doppler velocities in sickle cell anemia: results from the SWiTCH trial. Blood. 2014 Aug 7;124(6):891-8. doi: 10.1182/blood-2013-12-545186. Epub 2014 Jun 9.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease and Brain Injuries, run by Eman Abdul-Hai.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman DR Abdelhai Fathi Soliman, (M.S.C) of pediatric (01028820014, eimanabdelhai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
silent parenchymal and vascular brain changes in Sickle cell disease. (time frame: TWO YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06498726, which also lists 2 linked publications.
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 12 Jul 2024.