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NCT Number: NCT06498726

Role of Transcranial Doppler and Magnetic Resonance Angiography for Future Management of Sickle Cell Anemia CNS.

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • 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

Treatment and study plan

Transcranial Doppler

Device

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

Other names: MRA

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eman DR Abdelhai Fathi Soliman, (M.S.C) of pediatric

CONTACT

[email protected]

01028820014

Khalid PROF. Ibrahim Abdel-Rahman, Professor of pediatrics

CONTACT

[email protected]

01005484357

Sponsors and collaborators

Lead sponsor

Eman Abdul-Hai

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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