Granulocyte transfusions for treating infections in patients with neutropenia or neutrophil dysfunction

Randomized phase III study of granulocyte transfusions in neutropenic patients

“…4,10,14,16,17,19,[25][26][27] This study raises issues about the ethical feasibility of randomization of a safe and potentially life-saving treatment with level II-2 (or C) evidence of efficacy, points out future technical and clinical challenges, as well as recommendations for a still missing valid randomized controlled trial to obtain level I (A) evidence of the efficacy of GT treatment:…”

“…[6][7][8][9][10][11][12][13][14][15] However, published studies rely on clinical observations of individual cases or series (highest evidence level II-2 or C), and no valid statistical comparison of this treatment method with control groups has been performed. 16,17 This prospective phase III study aims to compare the efficacy, safety and toxicity of GT in a randomized setting with standard antimicrobial treatment in 74 patients with febrile neutropenia and invasive, life-threatening infections, and to evaluate the possible alteration of incidence and severity of GVHD in 39 allografted patients due to allo-immunization.…”

Efficacy of transfusion with granulocytes from G-CSF/dexamethasone–treated donors in neutropenic patients with infection

“…[10][11][12][13][14] Finally, many physicians were not convinced that their patients experienced meaningful clinical improvements after receiving granulocyte transfusions, which has been attributed, at least in part, to the likelihood that the doses of granulocytes administered, typically 20 to 30 3 10 9 , were inadequate. Evidence for the importance of dose came from early uncontrolled trials in humans, 15,16 from retrospective analysis of the early controlled trials, 9,17,18 from animal studies using sepsis and meningitis models, 19,20 and from human kinetic studies showing that normal daily neutrophil production in the uninfected subject was ;1 3 10 9 /kg. 21 Renewed interest in this therapy arose with the introduction of granulocyte colonystimulating factor (G-CSF) and the possibility of greatly increasing the dose of granulocytes transfused by administering G-CSF to healthy granulocyte donors.…”

Single-donor granulocyte transfusions for improving the outcome of high-risk pediatric patients with known bacterial and fungal infections undergoing stem cell transplantation: a 10-year single-center experience

“…We observed that 2-3 weekly transfusions prevented progression or de novo development of bacterial and fungal infections along with standard antimicrobial treatment. [21][22][23][24][25] Larger randomized studies are required to confirm the efficacy of prophylactic GTs in such patients and in particular to assess the potential of GTs for reducing aGvHD.…”