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NCT00627393 · OUTCOME

Serious Adverse Events in Granulocyte Donors

Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study) · Source last updated 2015-04-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Measured at Week 1 after G-CSF administration

Analysis population: 237 subjects consented to G-CSF and dexamethasone administration prior to granulocyte donation.

Groups in this outcome

Granulocyte Donors

Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth. Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Granulocyte Donors237

Reported measurements

Myalgia and backpain of unexpected duration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Granulocyte Donors1Not reportedNot reportedNot reportedNot reported
Abnormal nucleated red blood cell differential
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Granulocyte Donors1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Myalgia and backpain of unexpected duration
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Abnormal nucleated red blood cell differential
denoms
  1. counts
    1. group Id
      OG000
      value
      237
    units
    Participants
groups
  1. description
    Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth. Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants.
    id
    OG000
    title
    Granulocyte Donors
param Type
NUMBER
population Description
237 subjects consented to G-CSF and dexamethasone administration prior to granulocyte donation.
reporting Status
POSTED
time Frame
Measured at Week 1 after G-CSF administration
title
Serious Adverse Events in Granulocyte Donors
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice