Adverse Blood Transfusion Outcomes: Establishing Causation

James P. Isbister, Aryeh Shander, Donat R. Spahn, Jochen Erhard, Shannon L. Farmer, Axel Hofmann

    Research output: Contribution to journalArticle

    104 Citations (Scopus)

    Abstract

    The transfusion of allogeneic red blood cells (RBCs) and other blood components is ingrained in modern medical practice. The rationale for administering transfusions is based on key assumptions that efficacy is established and risks are acceptable and minimized. Despite the cliché that, "the blood supply is safer than ever," data about risks and lack of efficacy of RBC transfusions in several clinical settings have steadily accumulated. Frequentist statisticians and clinicians demand evidence from randomized clinical trials (RCTs); however, causation for the recognized serious hazards of allogeneic transfusion has never been established in this manner. On the other hand, the preponderance of evidence implicating RBC transfusions in adverse clinical outcomes related to immunomodulation and the storage lesion comes from observational studies, and a broad and critical analysis to evaluate causation is overdue. It is suggested in several circumstances that this cannot wait for the design, execution, and conduct of rigorous RCTs. We begin by examining the nature and definition of causation with relevant examples from transfusion medicine. Deductive deterministic methods may be applied to most of the well-accepted and understood serious hazards of transfusion, with modified Koch's postulates being fulfilled in most circumstances. On the other hand, when several possible interacting risk factors exist and RBC transfusions are associated with adverse clinical outcomes, establishing causation requires inferential probabilistic methodology. In the latter circumstances, the case for RBC transfusions being causal for adverse clinical outcomes can be strengthened by applying modified Bradford Hill criteria to the plethora of existing observational studies. This being the case, a greater precautionary approach to RBC transfusion is necessary and equipoise that justifying RCTs may become problematic.

    Original languageEnglish
    Pages (from-to)89-101
    Number of pages13
    JournalTransfusion Medicine Reviews
    Volume25
    Issue number2
    DOIs
    Publication statusPublished - Apr 2011

    Fingerprint

    Erythrocyte Transfusion
    Blood Transfusion
    Causality
    Blood
    Randomized Controlled Trials
    Observational Studies
    Transfusion Medicine
    Hazards
    Immunomodulation
    Medicine
    Cells

    Cite this

    Isbister, J. P., Shander, A., Spahn, D. R., Erhard, J., Farmer, S. L., & Hofmann, A. (2011). Adverse Blood Transfusion Outcomes: Establishing Causation. Transfusion Medicine Reviews, 25(2), 89-101. https://doi.org/10.1016/j.tmrv.2010.11.001
    Isbister, James P. ; Shander, Aryeh ; Spahn, Donat R. ; Erhard, Jochen ; Farmer, Shannon L. ; Hofmann, Axel. / Adverse Blood Transfusion Outcomes : Establishing Causation. In: Transfusion Medicine Reviews. 2011 ; Vol. 25, No. 2. pp. 89-101.
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    Isbister, JP, Shander, A, Spahn, DR, Erhard, J, Farmer, SL & Hofmann, A 2011, 'Adverse Blood Transfusion Outcomes: Establishing Causation' Transfusion Medicine Reviews, vol. 25, no. 2, pp. 89-101. https://doi.org/10.1016/j.tmrv.2010.11.001

    Adverse Blood Transfusion Outcomes : Establishing Causation. / Isbister, James P.; Shander, Aryeh; Spahn, Donat R.; Erhard, Jochen; Farmer, Shannon L.; Hofmann, Axel.

    In: Transfusion Medicine Reviews, Vol. 25, No. 2, 04.2011, p. 89-101.

    Research output: Contribution to journalArticle

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