Evidence map›Paper›PMID 35977532›Full record

Trial reportActa haematologica2023

Stroke Prevention with Hydroxyurea Enabled through Research and Education: A Phase 2 Primary Stroke Prevention Trial in Sub-Saharan Africa.

Luke R Smart, Emmanuela E Ambrose, Georgina Balyorugulu, Primrose Songoro, Idd Shabani, Protas Komba, Mwesige Charles, Thad A Howard, Kathryn E McElhinney, Sara M O'Hara and 8 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Acta haematologica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03948867 (Stroke Prevention With Hydroxyurea Enabled Through Research and Education), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 22% 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.

NCT03948867 phase2active not recruitingnot on this map

Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE): A Prospective Trial to Reduce Primary Stroke in Children With Sickle Cell Anaemia

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2019 to 2026Enrolled202ConditionsSickle Cell Anemia in ChildrenArmsHydroxyurea, Elevated Arm TCD Examination, Normal Arm TCD Examination
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
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  7. 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

18 authors at 3 institutions in 2 countries.

Luke R SmartDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Emmanuela E AmbroseCatholic University of Health & Allied Sciences, Mwanza, Tanzania.
Georgina BalyoruguluCatholic University of Health & Allied Sciences, Mwanza, Tanzania.
Primrose SongoroBugando Medical Centre, Mwanza, Tanzania.
Idd ShabaniCatholic University of Health & Allied Sciences, Mwanza, Tanzania.
Protas KombaBugando Medical Centre, Mwanza, Tanzania.
Mwesige CharlesBugando Medical Centre, Mwanza, Tanzania.
Thad A HowardDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Kathryn E McElhinneyDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Sara M O'HaraDepartment of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Jodie OdameDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Maria NakafeeroDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Janet AdamsDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Susan E StuberDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Adam LaneDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Teresa S LathamDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Abel N MakubiCatholic University of Health & Allied Sciences, Mwanza, Tanzania.
Russell E WareDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Cincinnati Children's Hospital Medical Center · USCatholic University of Health and Allied Sciences · TZBugando Medical Centre · TZ

Funding

Sickle Cell Anemia, Splenic Pathology, and Hydroxyurea in Sub-Saharan AfricaK23HL153763 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI SMART, LUKE · 2020 to 2024
$848k
NHLBI NIH HHS K23 HL153763
6 · The paper itself

Abstract

introductionStroke is a severe complication of sickle cell anemia (SCA), with devastating sequelae. Transcranial Doppler (TCD) ultrasonography predicts stroke risk, but implementing TCD screening with suitable treatment for primary stroke prevention in low-resource environments remains challenging. SPHERE (NCT03948867) is a prospective phase 2 open-label hydroxyurea trial for SCA in Tanzania.

methodsAfter formal training and certification, local personnel screened children 2-16 years old; those with conditional (170-199 cm/s) or abnormal (≥200 cm/s) time-averaged mean velocities (TAMVs) received hydroxyurea at 20 mg/kg/day with dose escalation to maximum tolerated dose (MTD). The primary study endpoint is change in TAMV after 12 months of hydroxyurea; secondary endpoints include SCA-related clinical events, splenic volume and function, renal function, infections, hydroxyurea pharmacokinetics, and genetic modifiers.

resultsBetween April 2019 and April 2020, 202 children (average 6.8 ± 3.5 years, 53% female) enrolled and underwent TCD screening; 196 were deemed eligible by DNA testing. Most had numerous previous hospitalizations and transfusions, with low baseline hemoglobin (7.7 ± 1.1 g/dL) and %HbF (9.3 ± 5.4%). Palpable splenomegaly was present at enrollment in 49 (25%); average sonographic splenic volume was 103 mL (range 8-1,045 mL). TCD screening identified 22% conditional and 2% abnormal velocities, with hydroxyurea treatment initiated in 96% (45/47) eligible children.

conclusionSPHERE has built local capacity with high-quality research infrastructure and TCD screening for SCA in Tanzania. Fully enrolled participants have a high prevalence of elevated baseline TCD velocities and splenomegaly. SPHERE will prospectively determine the benefits of hydroxyurea at MTD for primary stroke prevention, anticipating expanded access to hydroxyurea treatment across Tanzania.

Indexed as

Anemia, Sickle CellStrokeAdolescentAfrica South of the SaharaChildChild, PreschoolFemaleHumansHydroxyureaMaleProspective StudiesSplenomegalyHydroxyureaHydroxyureaSickle cell anemiaStrokeSub-Saharan AfricaTranscranial Doppler

Identifiers

PMID35977532
PMCPMC10100573
OpenAlexW4292148736

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.