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NCT00627393 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Infection and Neutropenia, sponsored by Carelon Research.

Completed
Registry status
Phase 3
Development phase
114
Enrollment target
13
Study locations

NCT00627393 is a Phase 3 study of Infection and Neutropenia that has completed, run by Carelon Research. The registered enrollment target is 114 participants, below the 724-participant average among 41 other Infection trials with a reported enrollment target (84% lower). The trial reports 13 study locations across 9 states.

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The verdict

NCT00627393, a Phase 3 study of Infection and Neutropenia, has completed, sponsored by Carelon Research.

COMPLETED
Registry status
Phase 3
Development phase
114 participants
Enrollment target
13
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Standard antimicrobial therapy
  • BIOLOGICAL Granulocyte transfusions
  • DRUG G-CSF/dexamethasone
  • DEVICE Apheresis machine

Study Locations (13)

Pennsylvania

  • Chlidren's Hospital of Philadelphia - Philadelphia
  • University of Pennsylvania - Philadelphia
  • University of Pittsburgh Presbyterian and Shadyside - Pittsburgh

New York

  • Weill Medical College, Cornell University - New York
  • Montefiore Medical Center - The Bronx

Wisconsin

  • University of Wisconsin at Madison - Madison
  • Froedtert Memorial Lutheran Hospital - Milwaukee

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Maryland

  • Johns Hopkins Hospital - Baltimore

Massachusetts

  • Children's Hospital Boston - Boston

Minnesota

  • University of Minnesota - Minneapolis

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2008-04
Est. Completion 2013-05
Phase Phase 3

Sponsor

Carelon Research

50 total trials

What the Registry Record Tells You About NCT00627393

The ClinicalTrials.gov registry entry for NCT00627393 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 724-participant average among 41 other Infection trials with a reported enrollment target (84% lower). The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Infection appearing as the primary indexed condition, and to 4 interventions - of which Standard antimicrobial therapy is the first listed.

NCT00627393 reports 13 study locations spanning 9 distinct geographic areas - top geographies include Pennsylvania, New York, Wisconsin.

Frequently Asked Questions

What is clinical trial NCT00627393 about?

NCT00627393 is a clinical study titled "Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)". 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...

What is the current status of trial NCT00627393?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2008-04. Estimated completion is 2013-05.

What conditions does trial NCT00627393 study?

This clinical trial studies the following conditions: Infection, Neutropenia.

What interventions are being tested in trial NCT00627393?

The interventions under investigation include: Standard antimicrobial therapy (DRUG), Granulocyte transfusions (BIOLOGICAL), G-CSF/dexamethasone (DRUG), Apheresis machine (DEVICE).

Who is sponsoring clinical trial NCT00627393?

This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00627393 being conducted?

This trial has 13 study locations across Iowa, Maryland, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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