Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia

Sepsis Clinical Trial

Official title:

Efficacy of Granulocyte Transfusions for the Treatment of Severe Infections in Hematological Patients With Febrile Neutropenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544230
• Other study ID #: GTX.01
• Status: Completed
• Phase: N/A
• First received: September 4, 2015
• Last updated: September 5, 2015
• Start date: January 2004
• Est. completion date: December 2011

Study information

• Verified date: September 2015
• Source: Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Febrile Neutropenia
• Fever
• Fever of Unknown Origin
• Fungal Infection
• Hematologic Neoplasms
• Hematological Neoplasms
• Infection
• Mycoses
• Neutropenia
• Sepsis

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Dale DC, Price TH. Granulocyte transfusion therapy: a new era? Curr Opin Hematol. 2009 Jan;16(1):1-2. doi: 10.1097/MOH.0b013e32831d7953. — View 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;6:CD005341. doi: 10.1002/14651858.CD005341.pub3. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection-related mortality	deaths due to infection occurred within 30 days after the last granulocyte transfusion	within 30 days after the last granulocyte transfusion	No