NCT05434000: SPRING-COM

Primary Prevention of Stroke in Children With Sickle Cell Anaemia in Nigeria in the Community

Status unknown NA Last updated 1 August 2023

What this trial tests

NA trial testing Hydroxyurea in Sickle Cell Disease in 217 participants. Status unknown.

Timeline

6 January 2021

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	Barau Dikko Teaching Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	217
Start date	6 January 2021
Primary completion	31 July 2025
Estimated completion	31 July 2025
Sites	1 location across Nigeria

Drugs / interventions tested

• Hydroxyurea — full drug profile →

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →
• Stroke — all drugs for Stroke →

Sponsor

Barau Dikko Teaching Hospital

Who can join

Adults 2 to 16, any sex, with Sickle Cell Disease or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Barriers and facilitators to a task-shifted stroke prevention program for children with sickle cell anemia in a community hospital: a qualitative study.
   Bello-Manga H, Haliru L, Ahmed K, Ige S, et al · · 2024 · cited 2× · PMID 38225633 · DOI 10.1186/s43058-023-00534-z
2. Sickle cell anemia and early stroke detection and prevention in Nigeria.
   Ahmed KA, Bello-Manga H, Jordan LC. · · 2024 · PMID 41542277 · DOI 10.3389/fstro.2024.1368576
3. Barriers and Facilitators to a Task-Shifted Stroke Prevention Program for Children with Sickle Cell Anemia in a Community Hospital: A Qualitative Study
   Bello-Manga H, Haliru L, Ahmed K, Ige S, et al · · 2023 · DOI 10.21203/rs.3.rs-2985921/v1