Evidence map›Paper›PMID 25399822›Full record

Trial reportPediatric blood & cancer2015

Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): challenges of conducting a feasibility trial.

Najibah A Galadanci, Shehu U Abdullahi, Musa A Tabari, Shehi Abubakar, Raymond Belonwu, Auwal Salihu, Kathleen Neville, Fenella Kirkham, Baba Inusa, Yu Shyr and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Pediatric blood & cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01801423 (Primary Prevention of Strokes in Nigerian Children With Sickle Cell Disease Affiliated Titles), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01801423 nacompletednot on this map

Primary Prevention of Strokes in Nigerian Children With Sickle Cell Disease Affiliated Titles: Sickle Cell Disease - Stroke Prevention in Nigeria (SPIN) Trial

TypeinterventionalSponsorVanderbilt University Medical CenterRan2013 to 2019Enrolled29ConditionsSickle Cell Anemia, Sickle Cell Disease, StrokeArmsHydroxyurea
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
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  9. Review
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  14. Article
  15. Associations of transcranial doppler velocity, age, and gender with cognitive function in children with sickle cell anemia in Nigeria.Child neuropsychology : a journal on normal and abnormal development in childhood and adolescence · 2019
    Article
  16. Article
  17. Article
  18. Sickle Cell Disease in Sub-Saharan Africa.Hematology/oncology clinics of North America · 2016
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 3 countries.

Najibah A GaladanciDepartment of Haematology and Blood Transfusion, Bayero University/Aminu Kano Teaching Hospital, Kano, Nigeria.
Shehu U Abdullahi
Musa A Tabari
Shehi Abubakar
Raymond Belonwu
Auwal Salihu
Kathleen Neville
Fenella Kirkham
Baba Inusa
Yu Shyr
Sharon Phillips
Adetola A Kassim
Lori C Jordan
Muktar H Aliyu
Brittany V Covert
Michael R DeBaun
Aminu Kano Teaching Hospital · NGBayero University Kano · NGVanderbilt University · USVanderbilt University Medical Center · USEvelina London Children's Healthcare · GBUniversity College London · GBUniversity of Missouri–Kansas City · USVanderbilt Health · US

Funding

Research Training in Rehabilitation for Brain Injury and Neurological DisabilityT32HD007414 · NICHD · HUGO W. MOSER RES INST KENNEDY KRIEGER · PI Amy J. Bastian · 1991 to 2026
$6.3M
Vanderbilt-Emory-Cornell-Duke Consortium for Global Health Fellows (VECDor)R25TW009337 · FIC · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HEIMBURGER, DOUGLAS CORBETT, VERMUND, STEN H. · 2012 to 2016
$6.3M
Primary prevention of stroke in children with SCD in Sub-Saharan Africa IIR01NS094041 · NINDS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ABDULLAHI, SHEHU UMAR, ALIYU, MUKTAR HASSAN · 2015 to 2019
$5.4M
Stroke and Cardiovascular Research Training (SCaRT) InstituteD43TW009140 · FIC · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ADANU, RICHARD M K, ALABI, SULYMAN BIODUN · 2011 to 2023
$2.5M
Primary Prevention of Strokes in Nigerian Children with Sickle Cell DiseaseR21NS080639 · NINDS · VANDERBILT UNIVERSITY · PI ALIYU, MUKTAR HASSAN, DEBAUN, MICHAEL R. · 2012 to 2013
$282k
FIC NIH HHS 5D43TW009140-03FIC NIH HHS D43 TW009140FIC NIH HHS R25 TW009337NICHD NIH HHS T32 HD007414NINDS NIH HHS 1R21NS080639-01NINDS NIH HHS R01 NS094041NINDS NIH HHS R21 NS080639
6 · The paper itself

Abstract

backgroundThe majority of children with sickle cell disease (SCD), approximately 75%, are born in sub-Saharan Africa. For children with elevated transcranial Doppler (TCD) velocity, regular blood transfusion therapy for primary stroke prevention is standard care in high income countries, but is not feasible in sub-Saharan Africa. PROCEDURE: In the first U.S. National Institute of Health (NIH) sponsored SCD clinical trial in sub-Saharan Africa, we describe the protocol and challenges unique to starting a clinical trial in this region. We are conducting a single arm pilot trial of hydroxyurea therapy in children with TCD velocity ≥200 cm/sec in the middle cerebral arteries. Eligible children will be placed on hydroxyurea (n = 40) and followed for 3 years at Aminu Kano Teaching Hospital, Nigeria. Adherence will be measured via the Morisky Scale and adverse events will be determined based on hospitalization.

resultsOriginally, a randomized placebo trial was planned; however, placebo was not approved by the local Ethics Committee. Hence a single arm trial of hydroxyurea will be conducted and five controls per patient with normal TCD measurements will be followed to compare the rate of adverse events to those with abnormal TCD measurements taking hydroxyurea. Using non-NIH funding, over 9 months, multiple face-to-face investigator meetings were conducted to facilitate training.

conclusionA hydroxyurea trial (NCT01801423) for children with SCD is feasible in sub-Saharan Africa; however, extensive training and resources are needed to build a global patient oriented multi-disciplinary research team with a common purpose.

Indexed as

Anemia, Sickle CellStrokeAntisickling AgentsChildChild, PreschoolFeasibility StudiesFemaleFollow-Up StudiesGuideline AdherenceHumansHydroxyureaMaleMiddle Cerebral ArteryNigeriaPilot ProjectsUltrasonography, Doppler, TranscranialAntisickling AgentsHydroxyureahydroxyureaNigeriaprimary stroke preventionsickle cell disease

Identifiers

PMID25399822
PMCPMC4304992
OpenAlexW1480294594

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.