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

NCT06498726 | Not Yet Recruiting

• 1 other identifier: sickle cell anemia
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Blood Disease; Brain Injuries

Outcome Measures

Primary Outcomes (1)

• 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

  TWO YEARS

Study Arms (1)

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.

Device: transcranial doppler

Interventions

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

Also known as: MRA

1

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• (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.

You may not qualify if:

• \- 1.Other sickle cell syndromes were excluded because they had a lower or uncertain risk of stroke.
• 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

Sponsors & Collaborators

• Eman Abdul-Hai: lead

Related Publications (2)

• 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.

  PMID: 24391625 BACKGROUND

• Helton 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.

  PMID: 24914136 BACKGROUND

MeSH Terms

Conditions

Hematologic Diseases; Brain Injuries

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

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

CONTACT

01028820014; eimanabdelhai@gmail.com

Khalid PROF. Ibrahim Abdel-Rahman, Professor of pediatrics

CONTACT

01005484357; K.elsayh@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assiut

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 12, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07