Evidence map›Paper›PMID 38332651›Full record

Trial reportAmerican journal of hematology2024

Reducing transfusion utilization for children with sickle cell anemia in sub-Saharan Africa with hydroxyurea: Analysis from the phase I/II REACH trial.

Alexandra Power-Hays, George A Tomlinson, Leon Tshilolo, Brígida Santos, Thomas N Williams, Peter Olupot-Olupot, Luke R Smart, Banu Aygun, Adam Lane, Susan E Stuber and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in American journal of hematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01966731 (REALIZING EFFECTIVENESS ACROSS CONTINENTS WITH HYDROXYUREA), 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
3.5field-weighted citation impact, top 8% 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.

NCT01966731 phase1 / phase2active not recruitingnot on this map

Realizing effectiveness across continents with hydroxyurea (reach): a phase i/ii pilot study of hydroxyurea for children with sickle cell anemia

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2014 to 2033Enrolled635ConditionsSickle Cell DiseaseArmsHydroxyurea
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
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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

12 authors at 7 institutions in 6 countries.

Alexandra Power-HaysDivision of Hematology and Global Health Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.ORCID 0000-0002-5823-0218
George A TomlinsonDepartment of Medicine, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.
Leon TshiloloDepartment of Medicine, Centre Hospitalier Monkole, Kinshasa, Congo.ORCID 0000-0002-6318-0227
Brígida SantosInstituto Hematológico Pediátrico, Hospital Pediátrico David Bernardino, Luanda, Angola.
Thomas N WilliamsKEMRI-Wellcome Trust Programme, Kilifi, Kenya.ORCID 0000-0003-4456-2382
Peter Olupot-OlupotMbale Clinical Research Institute, Mbale Regional Referral and Teaching Hospital-Busitema University, Mbale, Uganda.
Luke R SmartDivision of Hematology and Global Health Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.ORCID 0000-0003-4083-0060
Banu AygunDivision of Hematology, Cohen Children's Medical Center of New York, New Hyde Park, New York, USA.ORCID 0000-0001-9934-5161
Adam LaneDivision of Hematology and Global Health Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Susan E StuberDivision of Hematology and Global Health Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Teresa LathamDivision of Hematology and Global Health Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Russell E WareDivision of Hematology and Global Health Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Cincinnati Children's Hospital Medical Center · USClínica Sagrada Esperança · AOCohen Children's Medical Center · USKenya Medical Research Institute · KEKinshasa General Hospital · CDMbale Hospital · UGUniversity Health Network · CA

Funding

Realizing Effectiveness Across Continents with Hydroxyurea(REACH): A Phase I/II Pilot Study of Hyroxyurea for Children with Sickle Cell AnemiaU01HL133883 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI Russell E Ware · 2017 to 2026
$10.6M
T32 Cincinnati Pediatric Clinical Pharmacology Training ProgramT32HD069054 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI TRACY A GLAUSER, Sonya C Tang Girdwood · 2011 to 2026
$3.0M
Sickle Cell Anemia, Splenic Pathology, and Hydroxyurea in Sub-Saharan AfricaK23HL153763 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI SMART, LUKE · 2020 to 2024
$848k
Doris Duke Charitable FoundationFIC NIH HHS L40 TW012438FIC NIH HHS L40TW012438NHLBI NIH HHS K23 HL153763NHLBI NIH HHS U01 HL133883NICHD NIH HHS T32 HD069054Wellcome Trust 091758Wellcome Trust 202800Wellcome Trust 202800/Z/16/Z
6 · The paper itself

Abstract

Children with sickle cell anemia (SCA) in Africa frequently require transfusions for SCA complications. Despite limited blood supplies, strategies to reduce their transfusion needs have not been widely evaluated or implemented. We analyzed transfusion utilization in children with SCA before and during hydroxyurea treatment. REACH (Realizing Effectiveness Across Continents with Hydroxyurea, NCT01966731) is a longitudinal Phase I/II trial of hydroxyurea in children with SCA from Angola, Democratic Republic of Congo, Kenya, and Uganda. After enrollment, children had a two-month pre-treatment screening period followed by 6 months of fixed-dose hydroxyurea (15-20 mg/kg/day), 18 months of dose escalation, and then stable dosing at maximum tolerated dose (MTD). Characteristics associated with transfusions were analyzed with univariate and multivariable models. Transfusion incidence rate ratios (IRR) across treatment periods were calculated. Among 635 enrolled children with 4124 person-years of observation, 258 participants (40.4%) received 545 transfusions. The transfusion rate per 100 person-years was 43.2 before hydroxyurea, 21.7 on fixed-dose, 14.5 during dose escalation, and 10.8 on MTD. During MTD, transfusion incidence was reduced by 75% compared to pre-treatment (IRR 0.25, 95% confidence interval [CI] 0.18-0.35, p < .0001), and by 50% compared to fixed dose (IRR 0.50, 95% CI 0.39-0.63, p < .0001). Hydroxyurea at MTD decreases transfusion utilization in African children with SCA. If widely implemented, universal testing and hydroxyurea treatment at MTD could potentially prevent 21% of all pediatric transfusions administered in sub-Saharan Africa. Increasing hydroxyurea access for SCA should decrease the transfusion burden and increase the overall blood supply.

Indexed as

Anemia, Sickle CellHydroxyureaAntisickling AgentsChildHumansKenyaUgandaAntisickling AgentsHydroxyurea

Identifiers

PMID38332651
PMCPMC11289910
OpenAlexW4391691583

What OpenQuestion holds

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LicenceCC BY
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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.