Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia

NCT ID: NCT02544230

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neutropenia Fever Bacterial Infection Fungal Infection Fever of Unknown Origin Hematological Neoplasms Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

OTHER

Sponsor Role lead

Responsible Party

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LIVIO PAGANO

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Sacred Heart

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 26118415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16034970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22712550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19057197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11236935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18070282 (View on PubMed)

Other Identifiers

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GTX.01

Identifier Type: -

Identifier Source: org_study_id

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