Primary prevention of stroke in children with sickle cell anemia in sub-Saharan Africa: rationale and design of phase III randomized clinical trial

Abdullahi, Shehu U.; Wudil, Binta J.; Bello‐Manga, Halima; Musa, Abuhuraira Ado; Gambo, Safiya; Galadanci, Najibah A.; Aminu, Hauwa; Gaya, Aliyu Tijjani; Sanusi, Surayya; Tabari, Musa A.; Galadanci, Aisha Amal; Borodo, Awwal Musa; Abba, Mohammed; Dambatta, Abdu Hamisu; Haliru, Lawal; Gambo, Awwal; Cassell, Holly; Rodeghier, Mark; Ghafuri, Djamila Labib; Greene, Brittany V. Covert; Neville, Kathleen; Kassim, Adetola A.; Kirkham, Fenella J.; Trevathan, Edwin; Jordan, Lori C.; Aliyu, Muktar H.; DeBaun, Michael R.

doi:10.1080/08880018.2020.1810183

Cited by 16 publications

(13 citation statements)

References 36 publications

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“…The SPRING trial was a three site, double-blind, randomized controlled trial that assigned 220 children with SCA and abnormal transcranial Doppler velocity (≥200 cm/second) to receive either low-dose (10 mg/kg/day) or moderate-dose (20mg/kg/day) hydroxyurea and included a comparison group of 220 J o u r n a l P r e -p r o o f children with normal TCD velocity (≤170 cm/sec). 4 The catchment area for the SPRING trial in northern Nigeria included at least 40,000 children with SCA. Participant inclusion criteria were children with confirmed hemoglobin SS or hemoglobin Sβ0 thalassemia, 5 to 12 years of age.…”

Section: Methodsmentioning

confidence: 99%

“…Significant barriers to preventing strokes in low-resource settings include inadequate safe blood supply and parent apprehension regarding the costs, safety, and feasibility of monthly blood transfusions. 4 As part of the National Institutes of Health (N.I.H. )-funded feasibility trial (Stroke Prevention in Nigeria (SPIN) trial, NCT01801423) and a subsequent R01-funded randomized controlled trial (Stroke Prevention in Nigeria (SPRING) trial, NCT02560935), we engaged in research capacity building, quality improvement efforts, and partnerships with state Nigerian governments to build a sustainable strategy for primary stroke prevention in children with SCA living in a low-resource setting.…”

Section: Introductionmentioning

confidence: 99%

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Capacity Building for Primary Stroke Prevention Teams in Children Living With Sickle Cell Anemia in Africa

Ghafuri¹,

Greene²,

Musa³

et al. 2021

Pediatric Neurology

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Capacity Building for Primary Stroke Prevention Teams in Children Living With Sickle Cell Anemia in Africa

Ghafuri¹,

Greene²,

Musa³

et al. 2021

Pediatric Neurology

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“…These figures for incidence are all less than the expected rate of 10.7 strokes per 100 PYO in the untreated arm of the STOP trial [ 117 ] ( Figure 1 B). In a randomised trial comparing 10 mg/kg and 20 mg/kg fixed dose hydroxyurea, the incidence rates of stroke were also both lower than the untreated arm of the STOP study and were not significantly different from each other [ 125 , 126 ].…”

Section: Strokementioning

confidence: 99%

Epidemiology of Stroke in Sickle Cell Disease

Kirkham

Lagunju

2021

JCM

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Sickle cell disease is the most common cause of stroke in childhood, both ischaemic and haemorrhagic, and it also affects adults with the condition. Without any screening or preventative treatment, the incidence appears to fall within the range 0.5 to 0.9 per 100 patient years of observation. Newborn screening with Penicillin prophylaxis and vaccination leading to reduced bacterial infection may have reduced the incidence, alongside increasing hydroxyurea prescription. Transcranial Doppler screening and prophylactic chronic transfusion for at least an initial year has reduced the incidence of stroke by up to 10-fold in children with time averaged mean of the maximum velocity >200 cm/s. Hydroxyurea also appears to reduce the incidence of first stroke to a similar extent in the same group but the optimal dose remains controversial. The prevention of haemorrhagic stroke at all ages and ischaemic stroke in adults has not yet received the same degree of attention. Although there are fewer studies, silent cerebral infarction on magnetic resonance imaging (MRI), and other neurological conditions, including headache, epilepsy and cognitive dysfunction, are also more prevalent in sickle cell disease compared with age matched controls. Clinical, neuropsychological and quantitative MRI screening may prove useful for understanding epidemiology and aetiology.

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“…AKTH investigators have been at the forefront of major studies on HIV and other disease conditions in Nigeria. [5][6][7][8][9][10] Bayero University Kano (BUK) is the academic home for clinical and basic science programs at AKTH. The…”

Section: Settingmentioning

confidence: 99%

“…4 Other grants at AKTH support clinical trials in HIV-associated kidney disease, sickle cell disease and childhood epilepsy. [5][6][7][8] Sustaining and scaling up this level of productivity requires complementary investments in research administration infrastructure.…”

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confidence: 99%

The V-RAMP program: Building research administration and management capacity in Nigeria

Aliyu

Iliyasu

Ingles

et al. 2021

Journal of Global Health Reports

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The increasing volume and complexity of research activities in Nigeria necessitates urgent measures to improve research infrastructure in grants administration and management. The Vanderbilt-Nigeria Research Administration and Management Training Program (V-RAMP) seeks to build infrastructure capacity in research administration and management and research ethics at a major teaching hospital in Nigeria. We will perform a mixed methods needs assessment of the administrative and management environment and develop an action plan to address infrastructure needs, prioritize processes, and guide program implementation. We will capacitate a newly established Office of Research Administration and improve the knowledge and skills of research administrators and grant managers via short term in-person trainings in Nashville, Tennessee and in Kano, Nigeria and through remote learning opportunities. We will enhance local administrative efficiency and performance of research ethics operations through training and mentoring of members and staff of the ethics review committee. Systematic processes to streamline protocols, including a Research Electronic Data Capture (REDCap) protocol tracking database and standard operating procedures in the responsible conduct of research and rigor and reproducibility will also be developed. V-RAMP will enable the creation of a high-quality research administration environment that is knowledgeable, efficient, and compliant regarding the fiscal, management and ethical standards of sponsored research.

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Primary prevention of stroke in children with sickle cell anemia in sub-Saharan Africa: rationale and design of phase III randomized clinical trial

Cited by 16 publications

References 36 publications

Capacity Building for Primary Stroke Prevention Teams in Children Living With Sickle Cell Anemia in Africa

Capacity Building for Primary Stroke Prevention Teams in Children Living With Sickle Cell Anemia in Africa

Epidemiology of Stroke in Sickle Cell Disease

The V-RAMP program: Building research administration and management capacity in Nigeria

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