Stroke Prevention in Young Adults With Sickle Cell Anemia

Running, not enrolling

Conditions studied: Sickle Cell Disease, Sickle Cell Anemia, Stroke, Ischemic, Silent Stroke, Silent Cerebral Infarct, Stroke

In brief

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.

Key facts

Study ID: NCT04808778
Run by: Vanderbilt University Medical Center
People needed: 250
Starts: 2021-05-17
Expected to finish: 2029-06-01
Last updated by the study team: 2025-09-05

Who can join

Age: 16 and older, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Young adults with co-morbidities that may have an impact on neurological status, such as epilepsy;
Young adults enrolled in clinical trials upon entry;
Participants with an implanted defibrillator or certain other implanted electronic or metallic devices contraindicated for MRI;
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.

Where it is running

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

Full record on ClinicalTrials.gov

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