ArticleContemporary clinical trials communications2024
Hydroxyurea therapy for neurological and cognitive protection in pediatric sickle cell anemia in Uganda (BRAIN SAFE II): Protocol for a single-arm open label trial.
Article in Contemporary clinical trials communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04750707 (Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda), which is not on this map. Cited by 6 papers.
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Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda: A Single Arm Open Label Trial, "BRAIN SAFE II"
Who cites it
6 citing papers in PubMed.
- Incident Stroke in Pediatric Sickle Cell Anemia Despite Overall Improved Transcranial Doppler Velocity in a Ugandan Hydroxyurea Trial: Antecedent and Ongoing Risks.Pediatric blood & cancer · 2025Trial
- Neurocognitive gains among Ugandan children with sickle cell anemia on hydroxyurea: 18-month interim trial results.Blood advances · 2025Trial
- Growth measurements in Ugandan children with sickle cell anaemia from a hydroxyurea (hydroxycarbamide) treatment trial relative to unaffected sibling controls.British journal of haematology · 2025Article
- Hydroxyurea to decrease stroke risk in children with sickle cell anemia: a systematic review and meta-analysis.Blood global hematology · 2025Article
- Brain Age Modeling and Cognitive Outcomes in Young Adults With and Without Sickle Cell Anemia.JAMA network open · 2025Article
- Prevention of stroke and cognitive decline in pediatric population in resource-limited settings.Frontiers in stroke · 2024Review
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Abstract
Background: Children with sickle cell anemia (SCA) in Sub-Saharan Africa are at high risk of sickle cerebrovascular injury (SCVI). Hydroxyurea, a commonly used disease-modifying therapy, may reduce SCVI resulting in potential impact on reducing stroke and cognitive dysfunction. We aim to test the impact of daily hydroxyurea therapy on these outcomes in Ugandan children with SCA. We hypothesized that hydroxyurea therapy over 36 months will prevent, stabilize or improve these complications of SCA. Methods: The BRAIN SAFE II study is an open label, single arm trial of daily hydroxyurea in 270 children with SCA (HbSS) in Uganda, ages 3-9 years. Following baseline assessments, participants began hydroxyurea therapy and are followed according to local guidelines. Standard hydroxyurea dose is escalated to maximum tolerated dose (MTD). SCVI is assessed by cerebral arterial velocity using Doppler ultrasound, with cognitive function determined by formal neurocognitive testing (primary outcomes). Structural SCVI is assessed by magnetic resonance imaging (MRI) and angiography (MRA) in a sub-sample of 90 participants ages >5 years. At trial midpoint (18 months) and completion (36 months), outcomes of age-specific assessments will be compared to baseline, as well as biomarkers of anemia, inflammation and malnutrition (secondary outcomes) to determine their relationships to primary outcomes. Conclusion: This trial will examine the impact of hydroxyurea on preventing or ameliorating SCA SCVI in children, assessed by reducing incident stroke, stroke risk and neurocognitive dysfunction. Trial results will provide critical insight into the role of hydroxyurea therapy on critical manifestations of SCVI in children with SCA. Trial registration: https://clinicaltrials.gov/ct2/show/NCT04750707 (registered 11 February 2021). Protocol version: BRAIN SAFE II Protocol Version 3.0, Mar 02, 2022.
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