Evidence map›Paper›PMID 25140956›Full record

Trial reportThe New England journal of medicine2014

Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia.

Michael R DeBaun, Mae Gordon, Robert C McKinstry, Michael J Noetzel, Desiree A White, Sharada A Sarnaik, Emily R Meier, Thomas H Howard, Suvankar Majumdar, Baba P D Inusa and 28 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00072761 (Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial), which is not on this map. Cited by 224 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
224citing papers in PubMed, 13 pooled it
30.2field-weighted citation impact, top 1% 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.

NCT00072761 phase3completednot on this map

Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial

TypeinterventionalSponsorWashington University School of MedicineRan2004 to 2013Enrolled196ConditionsSickle Cell Anemia, StrokeArmstransfusion therapy
3 · Its place in the literature

Who cites it

224 citing papers in PubMed, 13 syntheses or guidelines pooled it, 529 citations in OpenAlex.

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164 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors at 20 institutions in 4 countries.

Michael R DeBaunFrom the Department of Pediatrics, Division of Hematology-Oncology, Vanderbilt-Meharry Center of Excellence in Sickle Cell Disease, Vanderbilt University School of Medicine, Nashville (M.R.D.); Department of Ophthalmology and Visual Sciences, Division of Biostatistics (M.G.), Departments of Radiology and Pediatrics (R.C.M.), Neurology and Pediatrics (M.J.N.), and Psychology (D.A.W.), the Program in Occupational Therapy and Department of Pediatrics Hematology-Oncology (A.A.K.), and the Division of Biostatistics and Department of Internal Medicine (J.P.M.), Washington University School of Medicine, St. Louis; Department of Pediatrics, Division of Hematology-Oncology, Wayne State University, Detroit (S.A.S.); Center for Cancer and Blood Disorders, Children's National Medical Center, Department of Pediatrics, George Washington University Medical Center (E.R.M.), and Department of Pediatrics, Division of Hematology-Oncology, Georgetown University Hospital (C.E.G.) - all in Washington, DC; Department of Pediatrics, Division of Hematology-Oncology, University of Alabama at Birmingham, Birmingham (T.H.H.); Department of Pediatrics, Division of Hematology-Oncology, University of Mississippi Medical Center, Jackson (S.M.); Department of Paediatrics, Evelina Children's Hospital, St. Thomas' Hospital NHS Trust (B.P.D.I.), Department of Pediatric Hematology, Royal London Hospital, Barts Health NHS Trust (P.T.T.), and the Neurosciences Unit, Institute of Child Health, University College London (F.J.K.) - all in London; Hospital for Sick Children, Department of Paediatrics, Haematology-Oncology, University of Toronto, Toronto (M.K.-A.); Division of Hematology-Oncology, Department of Pediatrics, UT Southwestern Medical Center, Dallas (T.L.M.C.); Département Pédiatrie, Hôpital Intercommunal de Creteil, Creteil, France (A.K.); Department of Pediatrics, Division of Hematology-Oncology, Baylor College of Medicine, Houston (G.A.); Department of Pediatrics, Hematology-Oncology, Univer
Mae Gordon
Robert C McKinstry
Michael J Noetzel
Desiree A White
Sharada A Sarnaik
Emily R Meier
Thomas H Howard
Suvankar Majumdar
Baba P D Inusa
Paul T Telfer
Melanie Kirby-Allen
Timothy L McCavit
Annie Kamdem
Gladstone Airewele
Gerald M Woods
Brian Berman
Julie A Panepinto
Beng R Fuh
Janet L Kwiatkowski
Allison A King
Jason M Fixler
Melissa M Rhodes
Alexis A Thompson
Mark E Heiny
Rupa C Redding-Lallinger
Fenella J Kirkham
Natalia Dixon
Corina E Gonzalez
Karen A Kalinyak
Charles T Quinn
John J Strouse
J Philip Miller
Harold Lehmann
Michael A Kraut
William S Ball
Deborah Hirtz
James F Casella
Cincinnati Children's Hospital Medical Center · USPediatrics and Genetics · USGeorgetown University · USBarts Health NHS Trust · GBBaylor College of Medicine · USCase Western Reserve University · USCenter for Cancer and Blood Disorders · USGreat Ormond Street Hospital · GBHôpital Intercommunal de Créteil · FRJohns Hopkins University · USLurie Children's Hospital · USNational Institutes of Health · USSinai Hospital · USSt. Thomas Hospital · CAThe Ohio State University · USThe University of Texas Southwestern Medical Center · USUniversity College London · GBUniversity of Alabama at Birmingham · USUniversity of Indianapolis · USUniversity of Mississippi Medical Center · US

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Institutional Clinical and Translational Science AwardUL1TR000003 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2012 to 2015
$38.9M
Silent Cerebral Infarct Multi-Center Clinical TrialU01NS042804 · NINDS · WASHINGTON UNIVERSITY · PI DEBAUN, MICHAEL R. · 2003 to 2010
$20.7M
NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1TR000003NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1TR000448NCATS NIH HHS UL1 TR001079NCATS NIH HHS UL1TR001079NINDS NIH HHS 3U01NS042804NINDS NIH HHS 5U01NS042804NINDS NIH HHS U01 NS042804
6 · The paper itself

Abstract

backgroundSilent cerebral infarcts are the most common neurologic injury in children with sickle cell anemia and are associated with the recurrence of an infarct (stroke or silent cerebral infarct). We tested the hypothesis that the incidence of the recurrence of an infarct would be lower among children who underwent regular blood-transfusion therapy than among those who received standard care.

methodsIn this randomized, single-blind clinical trial, we randomly assigned children with sickle cell anemia to receive regular blood transfusions (transfusion group) or standard care (observation group). Participants were between 5 and 15 years of age, with no history of stroke and with one or more silent cerebral infarcts on magnetic resonance imaging and a neurologic examination showing no abnormalities corresponding to these lesions. The primary end point was the recurrence of an infarct, defined as a stroke or a new or enlarged silent cerebral infarct.

resultsA total of 196 children (mean age, 10 years) were randomly assigned to the observation or transfusion group and were followed for a median of 3 years. In the transfusion group, 6 of 99 children (6%) had an end-point event (1 had a stroke, and 5 had new or enlarged silent cerebral infarcts). In the observation group, 14 of 97 children (14%) had an end-point event (7 had strokes, and 7 had new or enlarged silent cerebral infarcts). The incidence of the primary end point in the transfusion and observation groups was 2.0 and 4.8 events, respectively, per 100 years at risk, corresponding to an incidence rate ratio of 0.41 (95% confidence interval, 0.12 to 0.99; P=0.04).

conclusionsRegular blood-transfusion therapy significantly reduced the incidence of the recurrence of cerebral infarct in children with sickle cell anemia. (Funded by the National Institute of Neurological Disorders and Stroke and others; Silent Cerebral Infarct Multi-Center Clinical Trial ClinicalTrials.gov number, NCT00072761, and Current Controlled Trials number, ISRCTN52713285.).

Indexed as

Blood TransfusionAdolescentAnemia, Sickle CellCerebral InfarctionChildChild, PreschoolFemaleFerritinsHemoglobin, SickleHumansIntelligenceIntention to Treat AnalysisMaleSecondary PreventionSingle-Blind MethodTransfusion ReactionFerritinsHemoglobin, Sickle

Identifiers

PMID25140956
PMCPMC4195437
OpenAlexW2095095757

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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.