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Post-Transplant Events

Randomized phase III study of granulocyte transfusions in neutropenic patients

Bone Marrow Transplantation volume 42, pages 679–684 (2008)Cite this article

Abstract

Despite antibiotics, antifungals and haematopoietic growth factors, infections remain a major threat to neutropenic patients. To determine the role of granulocyte transfusions (GTs) in anti-infective therapy during neutropenia, GT administration was randomized in 74 adults with haematological or malignant diseases, febrile neutropenia and pulmonary or soft-tissue infiltrates after conventional or high-dose chemotherapy, a majority of them after allo-SCT (n=39). Neutrophil reconstitution was equal in the treatment and control arm. GT toxicity was minimal. The probability of 28-day survival after randomization was >80% in both groups, and no effect of GT on survival until day 100 could be detected in patients with fungal (n=55), bacterial or unknown infection (n=17) and various levels of neutropenia (ANC <500 vs >500 × 106/l). These findings can be attributed primarily to procedural obstacles, such as long delay from randomization to first GT, low cell content and slow sequence of GT, difficulties in randomizing a safe and potentially life-saving treatment in severely endangered individuals, and a large proportion of rapidly recovering patients in both arms. The requirement of another trial in a more specific patient population with daily transfusions of sufficient numbers of granulocytes to support or refute the empirically acknowledged benefits of GT is discussed.

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Acknowledgements

We thank Drs U Pötschger and S Karlhuber for their expertise and help in statistics and data documentation/processing, respectively. Furthermore, we thank Amgen, Schering and Chugai Pharma for travel grants. CP, AW, HN and HE designed the study; MGS, AW, RM, AB, GS and WG collected data; MGS, CP and HE analysed and interpreted the data and drafted the manuscript. All authors revised the manuscript critically for intellectual content and approved of its final version.

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Author notes

  1. M G Seidel and C Peters: These authors contributed equally to this work.

Authors and Affiliations

  1. St Anna Kinderspital, Kinderspitalgasse, Vienna, Austria

    M G Seidel & C Peters

  2. Uniklinik Tübingen, Medizinische Klinik II, Tübingen, Germany

    A Wacker & H Northoff

  3. University Klinikum Essen, Institut für Transfusoinsmedizin, Hufelandstr., Essen, Germany

    R Moog

  4. Zentrum der Inneren Medizin Med. Klinik II, Frankfurt, Germany

    A Boehme

  5. University Hospital Münster, Med. Klinik und Poliklinik Innere Med.A, Münster, Germany

    G Silling

  6. Klinikum Schwäbisch Gemünd, Innere Medizin, Mutlangen, Germany

    W Grimminger

  7. Medizinische Klinik und Poliklinik II, University Hospital Würzburg, Würzburg, Germany

    H Einsele

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  1. M G Seidel
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Correspondence to H Einsele.

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Seidel, M., Peters, C., Wacker, A. et al. Randomized phase III study of granulocyte transfusions in neutropenic patients. Bone Marrow Transplant 42, 679–684 (2008). https://doi.org/10.1038/bmt.2008.237

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