Evidence map›Paper›PMID 23861242›Full record

Trial reportAmerican journal of hematology2013

Pain and other non-neurological adverse events in children with sickle cell anemia and previous stroke who received hydroxyurea and phlebotomy or chronic transfusions and chelation: results from the SWiTCH clinical trial.

Ofelia Alvarez, Nancy A Yovetich, J Paul Scott, William Owen, Scott T Miller, William Schultz, Alexandre Lockhart, Banu Aygun, Jonathan Flanagan, Melanie Bonner and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00122980 (Stroke With Transfusions Changing to Hydroxyurea), which is not on this map. Cited by 26 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 6 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT00122980 phase3terminatednot on this map

Stroke With Transfusions Changing to Hydroxyurea

TypeinterventionalSponsorSt. Jude Children's Research HospitalRan2006 to 2010Enrolled134ConditionsHemochromatosis, Cerebrovascular Accident, Anemia, Sickle Cell, Hematologic DiseasesArmsRed Cell Transfusions, Iron Chelation, Hydroxyurea, Phlebotomy
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 6 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Non-crisis related pain occurs in adult patients with sickle cell disease despite chronic red blood cell exchange transfusion therapy.Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis · 2022
    Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

Ofelia AlvarezDepartment of Pediatrics, Division of Pediatric Hematology, University of Miami, Miami, Florida.
Nancy A Yovetich
J Paul Scott
William Owen
Scott T Miller
William Schultz
Alexandre Lockhart
Banu Aygun
Jonathan Flanagan
Melanie Bonner
Brigitta U Mueller
Russell E Ware
Investigators of the Stroke With Transfusions Changing to Hydroxyurea Clinical Trial (SWiTCH)
Baylor College of Medicine · USCincinnati Children's Hospital Medical Center · USRho (United States) · USChildren's Hospital of The King's Daughters · USChildren's Medical Center · USDuke Medical Center · USKings County Hospital Center · USMedical College of Wisconsin · USUniversity of Miami · US

Funding

Stroke with Transfusions Changing to HydroxyureaU01HL078787 · NHLBI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI WARE, RUSSELL E · 2005 to 2010
$15.5M
Clincal and Translational Science AwardUL1TR000055 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI SHAKER, REZA NONE · 2012 to 2015
$11.3M
NCATS NIH HHS UL1 TR000055NHLBI NIH HHS U01 HL078787
6 · The paper itself

Abstract

To compare the non-neurological events in children with sickle cell anemia (SCA) and previous stroke enrolled in SWiTCH. The NHLBI-sponsored Phase III multicenter randomized clinical trial stroke with transfusions changing to hydroxyurea (SWiTCH) (ClinicalTrials.gov NCT00122980) compared continuation of chronic blood transfusion/iron chelation to switching to hydroxyurea/phlebotomy for secondary stroke prevention and management of iron overload. All randomized children were included in the analysis (intention to treat). The Fisher's Exact test was used to compare the frequency of subjects who experienced at least one SCA-related adverse event (AE) or serious adverse event (SAE) in each arm and to compare event rates. One hundred and thirty three subjects, mean age 13 ± 3.9 years (range 5.2-19.0 years) and mean time of 7 years on chronic transfusion at study entry, were randomized and treated. Numbers of subjects experiencing non-neurological AEs were similar in the two treatment arms, including SCA-related events, SCA pain events, and low rates of acute chest syndrome and infection. However, fewer children continuing transfusion/chelation experienced SAEs (P = 0.012), SCA-related SAEs (P = 0.003), and SCA pain SAEs (P = 0.016) as compared to children on the hydroxyurea/phlebotomy arm. The timing of phlebotomy did not influence SAEs. Older age at baseline predicted having at least 1 SCA pain event. Patients with recurrent neurological events during SWiTCH were not more likely to experience pain. In children with SCA and prior stroke, monthly transfusions and daily iron chelation provided superior protection against acute vaso-occlusive pain SAEs when compared to hydroxyurea and monthly phlebotomy.

Indexed as

Transfusion ReactionAcute Chest SyndromeAdolescentAdultAnemia, Sickle CellAntisickling AgentsBenzoatesChelation TherapyChildChild, PreschoolCohort StudiesDeferasiroxFemaleHumansHydroxyureaIncidenceAntisickling AgentsBenzoatesDeferasiroxHydroxyureaIron Chelating AgentsTriazoles

Identifiers

PMID23861242
PMCPMC4631259
OpenAlexW2089501021

What OpenQuestion holds

Textmetadata
LicenceTDM
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.