Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia

September 5, 2015 updated by: LIVIO PAGANO, Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University Of Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection-related mortality
Time Frame: within 30 days after the last granulocyte transfusion
deaths due to infection occurred within 30 days after the last granulocyte transfusion
within 30 days after the last granulocyte transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 5, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 5, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTX.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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