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Feasibility trial for primary stroke prevention in children with sickle cell anemia in Nigeria (SPIN trial)

Galadanci, NA; Abdullahi, SU; Vance, LD; Tabari, AM; Ali, S; Belonwu, R; Salihu, A; ... DeBaun, MR; + view all (2017) Feasibility trial for primary stroke prevention in children with sickle cell anemia in Nigeria (SPIN trial). American Journal of Hematology , 92 (8) pp. 780-788. 10.1002/ajh.24770. Green open access

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Abstract

The vast majority of children with sickle cell anemia (SCA) live in Africa, where evidence-based guidelines for primary stroke prevention are lacking. In Kano, Nigeria, we conducted a feasibility trial to determine the acceptability of hydroxyurea therapy for primary stroke prevention in children with abnormal transcranial Doppler (TCD) measurements. Children with SCA and abnormal non-imaging TCD measurements (≥200 cm/s) received moderate fixed-dose hydroxyurea therapy (∼20 mg/kg/day). A comparison group of children with TCD measurements <200 cm/s was followed prospectively. Approximately 88% (330 of 375) of families agreed to be screened, while 87% (29 of 33) of those with abnormal TCD measurements, enrolled in the trial. No participant elected to withdraw from the trial. The average mean corpuscular volume increased from 85.7 fl at baseline to 95.5 fl at 24 months (not all of the children who crossed over had a 24 month visit), demonstrating adherence to hydroxyurea. The comparison group consisted of initially 210 children, of which four developed abnormal TCD measurements, and were started on hydroxyurea. None of the monthly research visits were missed (n = total 603 visits). Two and 10 deaths occurred in the treatment and comparison groups, with mortality rates of 2.69 and 1.81 per 100 patient-years, respectively (P = .67). Our results provide strong evidence, for high family recruitment, retention, and adherence rates, to undertake the first randomized controlled trial with hydroxyurea therapy for primary stroke prevention in children with SCA living in Africa.

Type: Article
Title: Feasibility trial for primary stroke prevention in children with sickle cell anemia in Nigeria (SPIN trial)
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/ajh.24770
Publisher version: https://doi.org/10.1002/ajh.24770
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Science & Technology, Life Sciences & Biomedicine, Hematology, MEDICATION ADHERENCE SCALE, NEUROLOGICAL IMPAIRMENT, VELOCITY-MEASUREMENTS, IDENTIFYING CHILDREN, HYDROXYUREA TWITCH, FLOW VELOCITIES, DISEASE, TRANSFUSIONS, HYDROXYCARBAMIDE, MULTICENTER
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > UCL GOS Institute of Child Health > ICH Developmental Neurosciences Prog
URI: http://discovery.ucl.ac.uk/id/eprint/1555424
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