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The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria
NCT04800809 · View on ClinicalTrials.gov ↗
Study Summary
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 chi
Conditions Studied
Interventions
- OTHER This study does not entail offering any intervention; all data collected will be based on standard of care.
Study Locations (3)
Other
- Jamil Galadanci — Kano
- Aminu Kano Teaching Hospital — Kano
Tennessee
- Vanderbilt University Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2023-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04800809
The ClinicalTrials.gov registry entry for NCT04800809 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention — of which This study does not entail offering any intervention; all data collected will be based on standard of care. is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04800809 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Other, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04800809 about?
NCT04800809 is a clinical study titled "The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria". 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, particula...
What is the current status of trial NCT04800809?
This trial is currently completed. The enrollment target is 350 participants. The study started on 2020-04-01. Estimated completion is 2023-12-31.
What conditions does trial NCT04800809 study?
This clinical trial studies the following conditions: Stroke, Sickle Cell Disease, Sickle Cell Anemia, Neurologic Manifestations, Sickle Cell Anemia in Children. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04800809?
The interventions under investigation include: This study does not entail offering any intervention; all data collected will be based on standard of care. (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04800809?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04800809 being conducted?
This trial has 3 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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