| 2008 Emily Cooley Memorial Lecture: lessons learned from pediatric transfusion medicine clinical trials . . . a little child shall lead them. | |
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MedLine Citation:
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PMID: 19527476 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Many clinical practices in transfusion medicine are controversial and/or lack definitive guidelines established by sound clinical trials. Although recommendations based on results of clinical trials performed using infants and children may not always be applied directly to adults--and vice versa--lessons learned from pediatric trials can be useful when critically assessing the design/results/conclusions of adult trials. STUDY DESIGN AND METHODS: Four randomized clinical trials (RCTs) studying pediatric patients were critically reviewed. They addressed two red blood cell (RBC) transfusion issues: 1) transfusion guidelines by which RBC transfusions are "triggered" by liberal (LIB; high pretransfusion patient hematocrit [Hct] levels) versus being "triggered" by restricted (RES; low pretransfusion Hct levels) and 2) transfusion of fresh RBCs (<or=7 days' storage) versus RBCs (up to 42 days' storage). RESULTS: Findings established by primary outcomes generally were firm (e.g., fewer RBC transfusions were given to infants/children managed by RES guidelines; transfusing small volumes of RBCs stored up to 42 days to preterm infants diminished allogeneic donor exposures and were equally efficacious and safe as fresh RBCs stored <or=7 days). Findings based on secondary outcomes, subset, and post hoc analyses were inconsistent (e.g., clinical outcomes were equivalent after LIB or RES transfusions in only two of three RCTs; in the third, more neurologic problems were found in neonates given RES transfusions). CONCLUSIONS: Clinical practices should be based on data pertaining to the primary outcomes of RCTs, because trials are designed and statistically powered to address these issues. Clinical practices suggested by analysis of secondary outcomes, subsets of patients, and post hoc analyses should be applied cautiously until studied further-ideally, as primary outcomes in subsequent RCTs. |
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Authors:
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Ronald G Strauss |
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Publication Detail:
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Type: Lectures; Research Support, N.I.H., Extramural Date: 2009-06-10 |
Journal Detail:
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Title: Transfusion Volume: 49 ISSN: 1537-2995 ISO Abbreviation: Transfusion Publication Date: 2009 Sep |
Date Detail:
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Created Date: 2009-09-08 Completed Date: 2009-09-23 Revised Date: 2010-09-07 |
Medline Journal Info:
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Nlm Unique ID: 0417360 Medline TA: Transfusion Country: United States |
Other Details:
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Languages: eng Pagination: 1996-2004 Citation Subset: IM |
Affiliation:
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Department of Pathology, University of Iowa Hospitals & Clinics, Iowa City, Iowa 52242-1009, USA. ronald-strauss@uiowa.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Age Factors Blood Preservation / methods, standards Child Child, Preschool Erythrocyte Transfusion / adverse effects, standards Erythrocytes / cytology Guidelines as Topic Hematocrit Humans Infant Infant, Newborn Randomized Controlled Trials as Topic* Time Factors |
| Grant Support | |
ID/Acronym/Agency:
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#P01-HL46925/HL/NHLBI NIH HHS; P01 HL046925-130008/HL/NHLBI NIH HHS |
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