drugset / Trial / NCT00627393

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

NCT00627393

RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2008-04
Primary completion
2013-04
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Granulocyte transfusions Cell therapy 4e+10 cells
Background Dexamethasone Small molecule Oral
Background Granulocyte colony-stimulating factor Protein / enzyme biologic Other