NCT04800809

The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria

Completed Last updated 23 April 2024

What this trial tests

trial testing This study does not entail offering any intervention; all data collected will be based on standard of care. in Sickle Cell Disease in 350 participants. Completed in 31 December 2023.

Timeline

1 April 2020

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	350
Start date	1 April 2020
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	3 locations across United States, Nigeria

Drugs / interventions tested

• This study does not entail offering any intervention; all data collected will be based on standard of care.

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →
• Stroke — all drugs for Stroke →
• Neurologic Manifestations — all drugs for Neurologic Manifestations →
• Neurological Morbidity — all drugs for Neurological Morbidity →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 5 to 26, any sex, with Sickle Cell Disease or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sickle Cell Anemia (SCA) occurs in 300,000 newborns per year in the world, with 150,000 affected births in Nigeria, alone. With improvement in survival for children with SCA in both high- and low-resource countries, neurological morbidity is an emerging significant public health challenge, particularly in countries with a high rate of sickle cell disease (SCD). Both silent cerebral infarcts (SCI) and overt strokes result in significant neurological morbidity and premature death. Five NIH-funded randomized controlled trials (RCT) demonstrated that regular blood transfusion or hydroxyurea therapy are efficacious treatments for primary and secondary stroke prevention in children with SCA. Despite the observation that at least 99% of children with SCA in high-resource settings reach adulthood, and approximately 60% of adults will experience one or more strokes (\~50% with SCI and \~10% with overt strokes) and the high disease-burden in Nigeria, the prevalence and incidence rates of new and recurrent stroke (overt and silent strokes)have not been collected systematically in children and young adults (16-25 years old) with SCA. In the last decade, there has been growing use of stroke registries in economically advanced nations, particularly for epidemiological purposes of trend analysis, clinical effectiveness, compliance to guidelines, assessment of implementation, adoption of novel techniques, and quality improvement process. For the first time in clinical centers in Nigeria, the Investigators will conduct an observational epidemiological study to document the prevalence and track the incidence of new and recurrent strokes in children and young adults with SCD. The Investigators will create a stroke registry referred to as the Afolabi Stroke Registry for Children and Young Adults with Sickle Cell Disease in Nigeria. The overall purpose of the stroke registry is to document the natural history of SCD in a low-resource setting and to improve the quality of the care of children and young adults with SCD living in Nigeria.

Publications & conference data

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

1. Hydroxyurea for primary stroke prevention in children with sickle cell anaemia in Nigeria (SPRING): a double-blind, multicentre, randomised, phase 3 trial.
   Abdullahi SU, Jibir BW, Bello-Manga H, Gambo S, et al · · 2022 · cited 74× · PMID 34971579 · DOI 10.1016/s2352-3026(21)00368-9
2. Hydroxyurea for secondary stroke prevention in children with sickle cell anemia in Nigeria: a randomized controlled trial.
   Abdullahi SU, Sunusi S, Abba MS, Sani S, et al · · 2023 · cited 31× · PMID 36322937 · DOI 10.1182/blood.2022016620
3. Identifying strokes in Nigerian children with sickle cell disease as part of clinical trials: training curriculum for healthcare professionals in low-income settings.
   Ghafuri DL, Bello-Manga H, Kirkham FJ, Ciobanu M, et al · · 2024 · PMID 41542279 · DOI 10.3389/fstro.2024.1444718
4. Initial low and moderate dose of hydroxyurea has a durable impact on primary stroke prevention in low-income settings.
   Abdullahi SU, Galadanci NA, Bello-Manga H, Ibrahim UA, et al · · 2026 · PMID 41529221 · DOI 10.1182/bloodadvances.2025018364