NCT04808778Active, not recruiting
Stroke Prevention in Young Adults With Sickle Cell Anemia
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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 attacks, and silent cerebral infarcts) in young adults at the transition age from 16-25 years. The Investigators will also, for the first time, assess conventional risk factors of stroke in the general population to determine whether a different prevention strategy is required to reduce the incidence of neurological injury in this high-risk population.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 250 (actual)
- First submitted
- 17 Mar 2021
- Start date
- 17 May 2021
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Stroke, Sickle cell disease
- NCT number
- NCT04808778
What you commit to
- Study type: Observational
- Participants enrolled: 250
- From 17 May 2021 to the primary completion date, 1 Jun 2029
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Young adults with co-morbidities that may have an impact on neurological status, such as epilepsy;
- Young adults with known HIV diagnosis;
- Any other condition or chronic illness, which in the opinion of the site's Principal Investigator (PI) makes participation ill-advised or unsafe.
Other
- Young adults enrolled in clinical trials upon entry;
- Participants with an implanted defibrillator or certain other implanted electronic or metallic devices contraindicated for MRI;
Who the study is looking for
- Patients with hemoglobin S-S or Sβ0 thalassemia confirmed by hemoglobin electrophoresis or High-Performance Liquid Chromatography (HPLC);
- Participant is 16 through 25 years of age;
- Informed consent from participants above 18 years, and informed consent from a parent or legal guardian and assent of participants aged \< 18 years (assessment can take place up until the 26th birthday);
- Participant resides within an hour driving distance from the medical center to facilitate weekly phone calls between the scheduled monthly clinic visits;
- Participant is willing to be enrolled and followed for the duration of the study.
Age in the registry: 16 years to 26 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aminu Kano Teaching Hospital Coordinator of this site? Confirm its status | Kano | Nigeria | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.