Primary Prevention of Stroke in Children With Sickle Cell Anaemia in Nigeria in the Community
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
The overall goal of this feasibility study is to establish a standard of care stroke
prevention program for children with sickle cell anemia in a community hospital by task
shifting stroke detection and transcranial Doppler ultrasound screening to nurses. In
Nigeria, approximately 150,000 children with sickle cell anemia (SCA) are born annually,
accounting for more than half of the total births with SCA worldwide. In comparison, only
1,700 children with SCA are born in the United States annually. An estimated 11% of
unscreened and untreated children at increase of strokes with SCA will have at least one
stroke by 17 years of age. In high-income countries, evidence-based practices (EBP) for
primary stroke prevention in children with SCA involves screening for abnormal transcranial
Doppler ultrasound (TCD) velocity (>200cm/s) coupled with regular blood transfusion therapy
for at least one year followed by treatment with hydroxyurea is considered standard care.
This strategy decreases the risk of stroke by 92%. Due to safety and availability, regular
blood transfusion is not a viable option for primary stroke prevention in most low-income
settings, including Nigeria, where ~50% of the 300,000 children with SCA are born. Among each
birth cohort, 15,000 children will have stroke annually in Nigeria. The American Society of
Hematology (ASH) Central Nervous System Guidelines recommends moderate dose hydroxyurea
(20mg/kg) to children with SCA with abnormal TCD measurements, living in resource-constrained
settings where regular blood transfusions are not readily available. Our team has
demonstrated in a previous trial the feasibility of primary stroke prevention with
hydroxyurea in Kano, Nigeria. In 2016, as part of capacity building objective of Stroke
Prevention Trial in Nigeria (1R01NS094041-SPRING) at Barau Dikko Teaching Hospital in Kaduna,
TCD screening was adopted as standard of care. Before the trial, no TCD screening was done at
our trial site in Kaduna. Now, as standard care, physicians at the teaching hospital do TCD
screening, however, only 5.4% (1,101/20,040) of the eligible children with SCA living in
Kaduna, Nigeria were reached. Clearly, for there to be an appreciable impact on decreasing
the stroke rates in children with SCA living in Nigeria and elsewhere, applying the ASH
guidelines and a better implementation strategy to increase the TCD reach (proportion of
children eligible for TCD screening that are screened) is necessary. Therefore, objective of
this physician-mentored application is to conduct an Effectiveness-Implementation Feasibility
Trial is to test the test the hypothesis that the task-shifted site for primary stroke
prevention team in a community hospital will have a non-inferior effectiveness in identifying
children with abnormal TCD measurements when compared to primary stroke prevention team in a
teaching hospital in Kaduna, Nigeria. the investigators will conduct i) a needs assessment at
the community hospital to identify barriers and facilitators to the intervention, ii) Build
capacity for stroke detection and TCD screening and iii) Compare the effectiveness of a
physician-based stroke prevention program in a teaching hospital to a task-shifted stroke
prevention in a community hospital.