Evidence map›Paper›PMID 22318199›Full record

Trial reportBlood2012

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH).

Russell E Ware, Ronald W Helms, SWiTCH Investigators

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02561312 (Comparison of Two Methods of Transfusion for Stroke Prevention in Sickle Cell), which is not on this map. Cited by 137 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
137citing papers in PubMed, 13 pooled it
13.6field-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.

NCT02561312 completednot on this mapstarted 2015, after this paper: background citation

Comparison of Two Methods of Transfusion for Stroke Prevention in Sickle Cell

TypeobservationalSponsorChattanooga-Hamilton County Hospital AuthorityRan2015 to 2017Enrolled9ConditionsAnemia, Sickle Cell, Sickling Disorder Due to Hemoglobin SArmsRapid manual partial exchange transfusion, Simple Transfusion
3 · Its place in the literature

Who cites it

137 citing papers in PubMed, 13 syntheses or guidelines pooled it, 376 citations in OpenAlex.

  1. Pooled it
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  3. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022
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  10. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2017
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77 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Russell E WareCenter for Global Health, Baylor College of Medicine and Texas Children's Hospital, 1102 Bates Street, Houston, TX 77030, USA. reware@bcm.edu
Ronald W Helms
SWiTCH Investigators
Baylor College of Medicine · USRho (United States) · US

Funding

Stroke with Transfusions Changing to HydroxyureaU01HL078787 · NHLBI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI WARE, RUSSELL E · 2005 to 2010
$15.5M
Stroke with Transfusions Changing to Hydroxyurea (SWITCH) Trial Data CoordinatingU01HL078987 · NHLBI · RHO FEDERAL SYSTEMS DIVISION, INC. · PI HELMS, RONALD W. · 2005 to 2010
$4.2M
NHLBI NIH HHS U01 HL078787NHLBI NIH HHS U01-HL078787NHLBI NIH HHS U01 HL078987NHLBI NIH HHS U01-HL078987
6 · The paper itself

Abstract

Stroke is a devastating complication of sickle cell anemia (SCA) with high recurrence if untreated. Chronic transfusions reduce recurrent strokes but have associated morbidities including iron overload. Stroke With Transfusions Changing to Hydroxyurea (SWiTCH) was a multicenter phase 3 randomized trial comparing standard treatment (transfusions/chelation) to alternative treatment (hydroxyurea/phlebotomy) for children with SCA, stroke, and iron overload. SWiTCH was a noninferiority trial with a composite primary end point, allowing an increased stroke risk but requiring superiority for removing iron. Subjects on standard treatment received monthly transfusions plus daily deferasirox iron chelation. Subjects on alternative treatment received hydroxyurea plus overlap transfusions during dose escalation to maximum tolerated dose (MTD), followed by monthly phlebotomy. Subjects on standard treatment (N = 66) maintained 30% sickle hemoglobin (HbS) and tolerated deferasirox at 28.2 ± 6.0 mg/kg/d. Subjects on alternative treatment (N = 67) initiated hydroxyurea and 60 (90%) reached MTD at 26.2 ± 4.9 mg/kg/d with 29.1% ± 6.7% fetal hemoglobin (HbF). Adjudication documented no strokes on transfusions/chelation but 7 (10%) on hydroxyurea/phlebotomy, still within the noninferiority stroke margin. The National Heart, Lung, and Blood Institute closed SWiTCH after interim analysis revealed equivalent liver iron content, indicating futility for the composite primary end point. Transfusions and chelation remain a better way to manage children with SCA, stroke, and iron overload.

Indexed as

Secondary PreventionTransfusion ReactionAdolescentAnemia, Sickle CellAntisickling AgentsChildFemaleHumansHydroxyureaMaleMaximum Tolerated DosePhlebotomyPrognosisStrokeSurvival RateTreatment OutcomeAntisickling AgentsHydroxyurea

Identifiers

PMID22318199
PMCPMC3350359
OpenAlexW2053431904

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.