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NCT04808778 · ClinicalTrials.gov registry record
Stroke Prevention in Young Adults With Sickle Cell Anemia
A clinical trial of Stroke and Sickle Cell Disease, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- 250
- Enrollment target
- 2
- Study locations
NCT04808778: Active study of Stroke and Sickle Cell Disease, sponsored by Vanderbilt University Medical Center.
NCT04808778 is a study of Stroke and Sickle Cell Disease that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 250 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04808778, a study of Stroke and Sickle Cell Disease, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 2
- Study locations
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
Primary Outcome
To estimate the prevalence of neurological morbidity including SCIs, strokes, and cerebral vasculopathy.
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 |
What the registry record for NCT04808778 still lists
NCT04808778 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (98% lower).
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.
NCT04808778 reports a single indexed study location in Tennessee, Other.
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.
What interventions are being tested in trial NCT04808778?
The interventions under investigation include: Hydroxyurea therapy per standard care (DRUG).
Who is sponsoring clinical trial NCT04808778?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04808778's enrollment target sits among peer trials
250 86th of 454 higher than 366 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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