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Seidel, MG; Peters, C; Wacker, A; Northoff, H; Moog, R; Boehme, A; Silling, G; Grimminger, W; Einsele, H.
Randomized phase III study of granulocyte transfusions in neutropenic patients.
Bone Marrow Transplant. 2008; 42(10):679-684
Doi: 10.1038/bmt.2008.237
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Seidel Markus
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- 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 x 10(6)/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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Adolescent -
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Adult -
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Aged -
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Female -
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Granulocytes - transplantation
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Hematologic Diseases - complications Hematologic Diseases - therapy
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Humans -
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Infection - mortality Infection - therapy
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Leukocyte Transfusion -
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Male -
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Middle Aged -
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Neoplasms - complications Neoplasms - therapy
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Neutropenia - mortality Neutropenia - therapy
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Survival Rate -
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Treatment Outcome -
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Young Adult -
- Find related publications in this database (Keywords)
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granulocyte transfusions
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invasive mycosis
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febrile neutropenia
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randomized clinical trial
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SCT