NeutropeniaNCT02544230
Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia
An observational study of Neutropenia and Fever, run by Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia, Fever, Bacterial Infection
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neutropenia, Fever, Bacterial Infection, Fungal Infection, Fever of Unknown Origin, Hematological Neoplasms
- Keywords
- granulocyte transfusions
- Medical subject headings
- Neutropenia, Fever, Bacterial Infections, Mycoses, Fever of Unknown Origin, Hematologic Neoplasms, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection-related mortality
deaths due to infection occurred within 30 days after the last granulocyte transfusion
Measured: within 30 days after the last granulocyte transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJan 2004
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIVIO PAGANO, Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544230
- Sponsor's protocol ID
- GTX.01
- Status last verified
- Sep 2015
- First submitted
- 4 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26118415Stanworth 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.
PubMed 16034970Strauss 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.
PubMed 22712550Dale 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.
PubMed 19057197Lee 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.
PubMed 11236935Ofran 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.
PubMed 18070282
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Granulocyte Transfusions for the Treatment of Severe Infections in Hematological Patients With Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT02544230
- Acronym / sponsor ID
- GTX.01
- Conditions
- Neutropenia, Fever, Bacterial Infection, Fungal Infection, Fever of Unknown Origin, Hematological Neoplasms
- Keywords
- granulocyte transfusions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Sorveglianza Epidemiologica Infezioni Fungine Emopatie MaligneUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Background: PubMed 26118415Estcourt 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.
- Background: PubMed 16034970Stanworth 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.
- Background: PubMed 22712550Strauss 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.
- Background: PubMed 19057197Dale 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.
- Background: PubMed 11236935Lee 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.
- Background: PubMed 18070282Ofran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia and Fever, run by Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection-related mortality (time frame: within 30 days after the last granulocyte transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02544230, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.