Dataset Information

2008 Emily Cooley Memorial Lecture: lessons learned from pediatric transfusion medicine clinical trials . . . a little child shall lead them.

ABSTRACT:

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 (ResultsFindings 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 ConclusionsClinical 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.

SUBMITTER: Strauss RG

PROVIDER: S-EPMC2750829 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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Publications

2008 Emily Cooley Memorial Lecture: lessons learned from pediatric transfusion medicine clinical trials . . . a little child shall lead them.

Strauss Ronald G RG

Transfusion 20090610 9

<h4>Background</h4>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.<h4>Study design and methods</h4>Four randomized clinical ...[more]

PMID: 19527476

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Dataset Information

2008 Emily Cooley Memorial Lecture: lessons learned from pediatric transfusion medicine clinical trials . . . a little child shall lead them.

Background

Study design and methods

Publications

2008 Emily Cooley Memorial Lecture: lessons learned from pediatric transfusion medicine clinical trials . . . a little child shall lead them.

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