Evidence map›Paper›PMID 38953438›Full record

Trial reportAmerican journal of hematology2024

Hydroxyurea to prevent brain injury in children with sickle cell disease (HU Prevent)-A randomized, placebo-controlled phase II feasibility/pilot study.

James F Casella, Dana K Furstenau, Robert J Adams, Donald J Brambilla, Jeffrey D Lebensburger, James J Fehr, Lori C Jordan, Allison A King, Rebecca N Ichord, Robert C McKinstry and 19 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
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. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. 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

29 authors.

James F CasellaDepartment of Pediatrics, Division of Hematology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-2846-9420
Dana K FurstenauDepartment of Pediatrics, Division of Hematology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Robert J AdamsDepartment of Neurology, Medical University of South Carolina, Charleston, South Carolina, USA.
Donald J BrambillaResearch Triangle Institute (RTI) International, Rockville, Maryland, USA.
Jeffrey D LebensburgerDivision of Pediatric Hematology-Oncology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.
James J FehrDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California, USA.
Lori C JordanDepartment of Pediatrics, Division of Pediatric Neurology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID 0000-0001-7240-0415
Allison A KingDivision of Pediatric Hematology/Oncology, Washington University and St. Louis Children's Hospital, St. Louis, Missouri, USA.
Rebecca N IchordDepartment of Neurology and Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Robert C McKinstryMallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri, USA.
Michael A KrautDepartment of Radiology and Radiological Science, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Dennis W ShawDepartment of Radiology, Seattle Children's Hospital, Seattle, Washington, USA.
Desiree A WhiteDepartment of Psychological Brain Sciences, Washington University in St. Louis, St. Louis, Missouri, USA.
Donna A Whyte-StewartDivision of Nonmalignant Hematology, Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Radhika AvadhaniDepartment of Neurology and Neurosurgery, BIOS Clinical Trials Coordinating Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Emily A Barron-CasellaDepartment of Pediatrics, Division of Hematology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Alicia D CannonDepartment of Neuropsychology, Kennedy Krieger Institute, Baltimore, Maryland, USA.ORCID 0000-0003-0780-6464
Cyd K EatonBiostatistics, Epidemiology, and Data Management Core, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.
Kristin A RiekertDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Joanne E ShayDepartment of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Cynthia A Smith-SeidelDepartment of Psychology, Martinsburg Veterans Affairs Medical Center (VAMC), Martinsburg, West Virginia, USA.
Diane C WeissDepartment of Pediatrics, Division of Hematology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Noeleen D OstapkovichDepartment of Neurology and Neurosurgery, BIOS Clinical Trials Coordinating Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Krista VermillionVanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Kevin E TreineDepartment of Neurology and Neurosurgery, BIOS Clinical Trials Coordinating Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Claire E KingsburyDepartment of Pediatrics, Division of Hematology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0009-0002-6956-3816
John J StrouseDepartment of Medicine and Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.ORCID 0000-0003-0341-1457
Richard E ThompsonDepartment of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Daniel F HanleyDepartment of Neurology and Neurosurgery, BIOS Clinical Trials Coordinating Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
Washington University Institute of Clinical and Translational Sciences (UL1)UL1RR024992 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$45.4M
Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
Johns Hopkins University Trial Innovation CenterU24TR004440 · NCATS · JOHNS HOPKINS UNIVERSITY · PI DANIEL F HANLEY · 2023 to 2026
$19.6M
Overall: Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Center at VanderbiltP50HD103537 · NICHD · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Lea K Davis · 2020 to 2026
$10.3M
Hydroxyurea to Prevent CNS Complications of Sickle Cell Disease in ChildrenR34HL108756 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI CASELLA, JAMES F, DEBAUN, MICHAEL R. · 2011 to 2014
$1.1M
Hydroxyurea to Prevent the Central Nervous System Complications of Sickle Cell Disease in ChildrenU34HL148480 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI CASELLA, JAMES F · 2019 to 2019
$164k
NCATS NIH HHS U24 TR001609NCATS NIH HHS U24TR001609NCATS NIH HHS U24 TR004440NCATS NIH HHS U24TR004440NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR003098NCRR NIH HHS UL1 RR024992NHLBI NIH HHS R34 HL108756NHLBI NIH HHS U34 HL148480NICHD NIH HHS P50 HD103537
6 · The paper itself

Abstract

Central nervous system (CNS) injury is common in sickle cell disease (SCD) and occurs early in life. Hydroxyurea is safe and efficacious for treatment of SCD, but high-quality evidence from randomized trials to estimate its neuroprotective effect is scant. HU Prevent was a randomized (1:1), double-blind, phase II feasibility/pilot trial of dose-escalated hydroxyurea vs. placebo for the primary prevention of CNS injury in children with HbSS or HbS-β

Indexed as

Anemia, Sickle CellFeasibility StudiesHydroxyureaAntisickling AgentsBrain InjuriesCerebral InfarctionChild, PreschoolDouble-Blind MethodFemaleHumansInfantMalePilot ProjectsStrokeAntisickling AgentsHydroxyurea

Identifiers

PMID38953438
PMCPMC11502276

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.