The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria

Completed

Conditions studied: Sickle Cell Disease, Stroke, Neurologic Manifestations, Neurological Morbidity, Sickle Cell Anemia in Children, Sickle Cell Anemia

In brief

Sickle Cell Anemia (SCA) occurs in 300,000 newborns per year in the world, with 150,000 affected births in Nigeria, alone. With improvement in survival for children with SCA in both high- and low-resource countries, neurological morbidity is an emerging significant public health challenge, particularly in countries with a high rate of sickle cell disease (SCD). Both silent cerebral infarcts (SCI) and overt strokes result in significant neurological morbidity and premature death. Five NIH-funded randomized controlled trials (RCT) demonstrated that regular blood transfusion or hydroxyurea therapy are efficacious treatments for primary and secondary stroke prevention in children with SCA. Despite the observation that at least 99% of children with SCA in high-resource settings reach adulthood, and approximately 60% of adults will experience one or more strokes (\~50% with SCI and \~10% with overt strokes) and the high disease-burden in Nigeria, the prevalence and incidence rates of new and recurrent stroke (overt and silent strokes)have not been collected systematically in children and young adults (16-25 years old) with SCA. In the last decade, there has been growing use of stroke registries in economically advanced nations, particularly for epidemiological purposes of trend analysis, clinical effectiveness, compliance to guidelines, assessment of implementation, adoption of novel techniques, and quality improvement process. For the first time in clinical centers in Nigeria, the Investigators will conduct an observational epidemiological study to document the prevalence and track the incidence of new and recurrent strokes in children and young adults with SCD. The Investigators will create a stroke registry referred to as the Afolabi Stroke Registry for Children and Young Adults with Sickle Cell Disease in Nigeria. The overall purpose of the stroke registry is to document the natural history of SCD in a low-resource setting and to improve the quality of the care of children and young adults with SCD living in Nigeria.

Key facts

Study ID

NCT04800809

Run by

Vanderbilt University Medical Center

People needed

350

Starts

2020-04-01

Expected to finish

2023-12-31

Last updated by the study team

2024-04-23

Who can join

Age: 5 and older, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with sickle cell disease confirmed with hemoglobin electrophoresis or HPLC
• Age 5 to 26 years old
• Present within three months of stroke event that is diagnosed as a stroke by the local health care provider
• Medical records are available for review for the stroke event that occurred within 3 months
• Prior treatment in the SPIN, SPRING and SPRINT trials for primary or secondary stroke prevention

You may not qualify if…

• Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice
• Participants with contraindications to MRI, including individuals with MRI- incompatible foreign metal objects

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Jamil Galadanci — Kano, Nigeria
• Aminu Kano Teaching Hospital — Kano, Nigeria

Full record on ClinicalTrials.gov

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