Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)

Completed · Phase 3

Conditions studied: Neutropenia, Infection

In brief

Neutropenia, a condition characterized by an abnormally low number of infection-fighting white blood cells called neutrophils, commonly develops in people who have undergone chemotherapy or hematopoietic stem cell (HSC) transplantation. The severely reduced immunity of those with neutropenia can put them at risk of entry of life-threatening infections, making the implementation of treatments that increase white blood cell numbers important. Several studies have shown that the transfusion of donor granulocytes, a type of white blood cell that includes neutrophils, is effective in promoting the recovery of adequate numbers of granulocytes. However, granulocyte transfusions can cause side effects, and it is not known whether the success of the therapy outweighs the health risks of the side effects. This study will evaluate the safety and effectiveness of granulocyte transfusions in treating people with a bacterial or fungal infection during neutropenia.

Key facts

Study ID

NCT00627393

Run by

Carelon Research

People needed

114

Starts

2008-04-01

Expected to finish

2013-05-01

Last updated by the study team

2015-04-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe neutropenia (Absolute Neutrophil Count < 500/mm\^3) due to marrow failure caused by underlying disease or therapy
• Must have one of the following: fungemia; bacteremia; proven or presumptive invasive tissue bacterial infection; or proven, probable, or presumptive invasive fungal infection

You may not qualify if…

• Unlikely to survive 5 days
• Evidence that patient will not be neutropenic at least 5 days
• Previously enrolled in this study

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Weill Medical College, Cornell University — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Chlidren's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Presbyterian and Shadyside — Pittsburgh, Pennsylvania, United States
• University of Washington Medical Center — Seattle, Washington, United States
• University of Wisconsin at Madison — Madison, Wisconsin, United States
• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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