Clinical trial NCT02544230: Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia
Official title: Efficacy of Granulocyte Transfusions for the Treatment of Severe Infections in Hematological Patients With Febrile Neutropenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenia
Fever
Bacterial Infection
Fungal Infection
Fever of Unknown Origin
Hematological Neoplasms
Sepsis
Keywords: granulocyte transfusions
Lead sponsor: Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with malignant emopatia who received granulocyte transfusions as adjunctive therapy in the treatment of severe infection, unresponsive to appropriate antimicrobial therapy, which was incurred during neutropenia.

Brief summary: The investigators retrospectively evaluated the efficacy of granulocyte transfusions as adjunctive treatment for severe infections in neutropenic fever unresponsive to antimicrobial therapy in hematological patients.


Eligibility criteria: Inclusion Criteria:

* fever;
* presence of absolute neutrophil count \<0.5 x 10\^9/L
* evidence of bacterial or fungal infections (including clinical signs of infection, positive cultures or biopsy, and radiological evidences)
* unresponsiveness to appropriate antimicrobial therapy for at least 48 hours

Exclusion Criteria:

* none

Primary outcomes:
measure: Infection-related mortality
timeFrame: within 30 days after the last granulocyte transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
References:
citation: Estcourt LJ, Stanworth S, Doree C, Blanco P, Hopewell S, Trivella M, Massey E. Granulocyte transfusions for preventing infections in people with neutropenia or neutrophil dysfunction. Cochrane Database Syst Rev. 2015 Jun 29;2015(6):CD005341. doi: 10.1002/14651858.CD005341.pub3.
citation: Stanworth SJ, Massey E, Hyde C, Brunskill S, Lucas G, Navarrete C, Marks DI. Granulocyte transfusions for treating infections in patients with neutropenia or neutrophil dysfunction. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD005339. doi: 10.1002/14651858.CD005339.
citation: Strauss RG. Role of granulocyte/neutrophil transfusions for haematology/oncology patients in the modern era. Br J Haematol. 2012 Aug;158(3):299-306. doi: 10.1111/j.1365-2141.2012.09190.x. Epub 2012 Jun 19.
citation: Dale DC, Price TH. Granulocyte transfusion therapy: a new era? Curr Opin Hematol. 2009 Jan;16(1):1-2. doi: 10.1097/MOH.0b013e32831d7953. No abstract available.
citation: Lee JJ, Chung IJ, Park MR, Kook H, Hwang TJ, Ryang DW, Kim HJ. Clinical efficacy of granulocyte transfusion therapy in patients with neutropenia-related infections. Leukemia. 2001 Feb;15(2):203-7. doi: 10.1038/sj.leu.2402007.
citation: Ofran Y, Avivi I, Oliven A, Oren I, Zuckerman T, Bonstein L, Rowe JM, Dann EJ. Granulocyte transfusions for neutropenic patients with life-threatening infections: a single centre experience in 47 patients, who received 348 granulocyte transfusions. Vox Sang. 2007 Nov;93(4):363-9. doi: 10.1111/j.1423-0410.2007.00971.x.