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.
Vincent MboiziCatherine NabaggalaDeogratias MunubeJohn M SsenkusuPhillip KasiryeSamson KamyaMichael G KawooyaAmelia BoehmeFrank MinjaEzekiel MupereRobert OpokaCaterina RosanoNancy S GreenRichard IdroPublished in: medRxiv : the preprint server for health sciences (2024)
This open-label, single-arm 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 important insight into the role of hydroxyurea therapy on critical manifestations of SCVI in children with SCA.
Keyphrases
- open label
- phase iii
- phase ii
- study protocol
- clinical trial
- randomized controlled trial
- young adults
- sickle cell disease
- atrial fibrillation
- cerebral ischemia
- cardiovascular disease
- bipolar disorder
- stem cells
- oxidative stress
- type diabetes
- brain injury
- radiation therapy
- multiple sclerosis
- subarachnoid hemorrhage
- squamous cell carcinoma
- placebo controlled
- white matter
- functional connectivity
- resting state