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Stroke Prevention in Young Adults With Sickle Cell Anemia
NCT04808778 · View on ClinicalTrials.gov ↗
Study Summary
Sickle cell disease (SCD) is the most common genetic disease, affecting about 25 million people worldwide. Approximately 150,000 Nigerian children are born each year with sickle cell disease (SCD), making it the country with the largest burden of SCD in the world. Recent advancements in care for children with SCA have translated into improved survival of children in both high and low-resource settings. However, more complications of SCD are seen in those who survive to adulthood. Silent cerebral infarcts (SCI) and strokes are among the most devastating complications of SCD, affecting 40% and 10% of children, respectively. The overall goal of this study is to extend the Investigator's successful capacity-building effort in the assessment of neurological morbidity in children with SCD living in northern Nigeria (Kano) to young adults with SCD living in the same region. About 50% of all adults with SCD live in Nigeria. Despite the high prevalence of SCD in Africa, the neurological morbidity is not well characterized, limiting opportunities for primary and secondary stroke prevention strategies. At least 50% of young adults with sickle cell anemia (SCA), the most severe form of the disease, will have SCIs and an estimated 10% will have strokes, based on studies in high-resource settings. In high-resource settings, screening for abnormal transcranial Doppler (TCD) velocities in children with SCA, coupled with regular blood transfusion has resulted in a 92% reduction of relative risk for strokes. Despite this effective strategy, regular blood transfusion therapy does not seem sustainable in sub-Saharan Africa due to shortages and the risk of transfusion transmissible infections. Additionally, there is a lack of evidence-based stroke prevention strategies in young adults with SCA, either in the high-income or in low-resource settings. Based on the foregoing, the Investigators propose to determine the prevalence of neurological injury (overt stroke, transient ischemic atta
Conditions Studied
Interventions
- DRUG Hydroxyurea therapy per standard care
Study Locations (2)
Tennessee
- Vanderbilt University Medical Center — Nashville
Other
- Aminu Kano Teaching Hospital — Kano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-05-17 |
| Est. Completion | 2029-06-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04808778
The ClinicalTrials.gov registry entry for NCT04808778 describes a study currently listed as active not recruiting. 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 250 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 Hydroxyurea therapy per standard 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: NCT04808778 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Tennessee, Other. 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 NCT04808778 about?
NCT04808778 is a clinical study titled "Stroke Prevention in Young Adults With Sickle Cell Anemia". Sickle cell disease (SCD) is the most common genetic disease, affecting about 25 million people worldwide. Approximately 150,000 Nigerian children are born each year with sickle cell disease (SCD), making it the country with the largest burden of SCD in the world. Recent advancements in care for chi...
What is the current status of trial NCT04808778?
This trial is currently active not recruiting. The enrollment target is 250 participants. The study started on 2021-05-17. Estimated completion is 2029-06-01.
What conditions does trial NCT04808778 study?
This clinical trial studies the following conditions: Stroke, Sickle Cell Disease, Stroke, Ischemic, Sickle Cell Anemia, Silent Stroke. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04808778?
The interventions under investigation include: Hydroxyurea therapy per standard care (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04808778?
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 NCT04808778 being conducted?
This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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