NCT02544230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

7.9 years

First QC Date

September 4, 2015

Last Update Submit

September 5, 2015

Conditions

NeutropeniaFeverBacterial InfectionFungal InfectionFever of Unknown OriginHematological NeoplasmsSepsis

Keywords

granulocyte transfusions

Outcome Measures

Primary Outcomes (1)

  • Infection-related mortality

    deaths due to infection occurred within 30 days after the last granulocyte transfusion

    within 30 days after the last granulocyte transfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (6)

  • 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.

    PMID: 26118415BACKGROUND

  • 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.

    PMID: 16034970BACKGROUND

  • 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.

    PMID: 22712550BACKGROUND

  • 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.

    PMID: 19057197BACKGROUND

  • 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.

    PMID: 11236935BACKGROUND

  • 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.

    PMID: 18070282BACKGROUND

MeSH Terms

Conditions

NeutropeniaFeverBacterial InfectionsMycosesFever of Unknown OriginHematologic NeoplasmsSepsis

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfectionsNeoplasms by SiteNeoplasmsSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 9, 2015

Study Start

January 1, 2004

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

IT(1)