Trial · NCT00627393

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

NCT00627393, Phase 3, Completed, Carelon Research; results first posted 2014-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study). Trials, record NCT00627393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00627393

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)
NCT number: NCT00627393
Status: Completed
Phases: Phase 3
Enrollment: 114 participants, actual
Lead sponsor: Carelon Research
Conditions: Neutropenia, Infection
Interventions: Standard antimicrobial therapy, Granulocyte transfusions, G-CSF/dexamethasone, Apheresis machine
First posted: 2008-03-03
Last updated: 2015-04-17
Results first posted: 2014-12-23

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response	Measured at Day 42	Microbial response was defined as follows: * A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia. * Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization.
Secondary	Alloimmunization, Defined as the Appearance of Anti-human Leukocyte Antigen (HLA) or Antineutrophil Antibodies	Measured at Days 14 and 42
Secondary	Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Measured within 6 hours after end of transfusion
Secondary	Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation	Measured at Day 42	Time to GVHD incidence between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.
Secondary	Overall Incidence of Adverse Effects	Measured through Day 42
Secondary	Fever Resolution	Measured through Day 42	Fever resolution between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.
Secondary	Time to Negative Test for Fungal Antigenemia (e.g., Galactomannan Antigenemia Among Participants With Invasive Aspergillosis)	Measured at Days 7, 14, and 42
Secondary	Time to Negative Blood Culture for Participants With Positive Blood Culture at Baseline	Measured through Day 42
Secondary	Long-term Survival	Measured at Month 3
Secondary	Serious Adverse Events in Granulocyte Donors	Measured at Week 1 after G-CSF administration

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response	Measured at Day 42	All adjudicated or deceased subjects in intention-to-treat analyses.	percentage of participants	NUMBER
SECONDARY	Alloimmunization, Defined as the Appearance of Anti-human Leukocyte Antigen (HLA) or Antineutrophil Antibodies	Measured at Days 14 and 42
SECONDARY	Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Measured within 6 hours after end of transfusion	Subjects who received granulocyte transfusions. Six subjects in the control group received granulocyte transfusions in violation of the protocol.	participants	NUMBER
SECONDARY	Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation	Measured at Day 42	Subjects who had allogeneic stem cell transplantation	proportion of subjects, GVHD incidnence	NUMBER
SECONDARY	Overall Incidence of Adverse Effects	Measured through Day 42	All randomized subjects.	participants	NUMBER
SECONDARY	Fever Resolution	Measured through Day 42	Subjects who had fever at baseline.	proportion of subjects, resolved fever	NUMBER
SECONDARY	Time to Negative Test for Fungal Antigenemia (e.g., Galactomannan Antigenemia Among Participants With Invasive Aspergillosis)	Measured at Days 7, 14, and 42
SECONDARY	Time to Negative Blood Culture for Participants With Positive Blood Culture at Baseline	Measured through Day 42
SECONDARY	Long-term Survival	Measured at Month 3	All randomized subjects.	participants	NUMBER
SECONDARY	Serious Adverse Events in Granulocyte Donors	Measured at Week 1 after G-CSF administration	237 subjects consented to G-CSF and dexamethasone administration prior to granulocyte donation.	participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response	Control Arm		42.9	percentage of participants
Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response	Granulocyte Arm		41.7	percentage of participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Control Arm	No events reported	5	participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Granulocyte Arm	No events reported	19	participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Control Arm	Grade 1	0	participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Granulocyte Arm	Grade 1	7	participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Control Arm	Grade 2	1	participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Granulocyte Arm	Grade 2	14	participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Control Arm	Grade 3	0	participants
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)	Granulocyte Arm	Grade 3	10	participants

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Intention-To-Treat Analysis	STARTED	Control Arm	58
Intention-To-Treat Analysis	STARTED	Granulocyte Arm	56
Intention-To-Treat Analysis	COMPLETED	Control Arm	49
Intention-To-Treat Analysis	COMPLETED	Granulocyte Arm	48
Intention-To-Treat Analysis	NOT COMPLETED	Control Arm	9
Intention-To-Treat Analysis	NOT COMPLETED	Granulocyte Arm	8
Per-Protocol Analysis	STARTED	Control Arm	49
Per-Protocol Analysis	STARTED	Granulocyte Arm	48
Per-Protocol Analysis	COMPLETED	Control Arm	39
Per-Protocol Analysis	COMPLETED	Granulocyte Arm	35

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events116

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Allergic reaction/ hypersensitivity	Immune system disorders	Control Arm	0	6	0
other	Allergic reaction/ hypersensitivity	Immune system disorders	Granulocyte Arm	5	51	5
other	Sinus bradycardia	Cardiac disorders	Control Arm	0	6	0
other	Sinus bradycardia	Cardiac disorders	Granulocyte Arm	0	51	0
other	Sinus tachycardia	Cardiac disorders	Control Arm	1	6	3
other	Sinus tachycardia	Cardiac disorders	Granulocyte Arm	17	51	36
other	Hypertension	General disorders	Control Arm	1	6	1
other	Hypertension	General disorders	Granulocyte Arm	9	51	15
other	Hypotension	General disorders	Control Arm	0	6	0
other	Hypotension	General disorders	Granulocyte Arm	10	51	14

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control Arm
Total, all-cause mortality	Granulocyte Arm
Total, other adverse events	Control Arm	1	6
Total, other adverse events	Granulocyte Arm	32	51
Total, serious adverse events	Control Arm	25	58
Total, serious adverse events	Granulocyte Arm	26	56

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26333778	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL072268	Transfusion Medicine/Hemostasis Clinical Trials Network-Data Coordinating Center	ASSMANN, SUSAN FERA	NEW ENGLAND RESEARCH INSTITUTES, INC.	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2002 to 2012

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Granulocyte Arm vs Control Arm: Long-term Survival	Trial comparisons
Granulocyte Arm vs Control Arm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00627393

GET https://conductscience.org/api/trials/v1/NCT00627393/results?page=2

API reference For AI assistants