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G-CSF for Granulocyte Donation
This study has been completed.
First Received: July 31, 2007   Last Updated: March 3, 2008   History of Changes
Sponsor: National Institutes of Health Clinical Center (CC)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001842
  Purpose

This study will examine the feasibility of giving cell growth stimulants to granulocyte donors the same day of donation rather than the day before.

People who donate granulocytes (infection-fighting white blood cells) for transfusion to patients with severe white cell deficiencies are often given a steroid called dexamethasone and a growth factor called G-CSF the day before donation. These drugs stimulate white cell production, allowing many more cells to be collected than would otherwise be possible. A single dose of G-CSF given to healthy people increases their white cells counts by four to five times the next day.

It would be preferable, however, to give G-CSF the same day of donation, if possible. Therefore, this study will measure white cell counts in healthy people at various intervals after being injected with G-CSF alone and G-CSF with dexamethasone. The study will compare the following: granulocyte counts at seven different intervals after injection of the drug or drugs; the effects of G-CSF injected through a vein or under the skin; and the effects of giving G-CSF alone or with dexamethasone.

Each participant will undergo four procedures, each four weeks apart as follows: donate a small blood sample; receive an injection of G-CSF under the skin or into a vein; and take either two dexamethasone tablets or two placebo tablets.

Small blood samples will then be drawn 1, 2, 4, 6, 8, and 24 hours after the drugs are given. Participants will answer questions about how they feel before the drugs are given and at the various intervals after taking the drugs.


Condition Intervention Phase
Healthy
Drug: Granulocyte colony-stimulating factor
Drug: Dexamethasone
Phase I

Study Type: Interventional
Study Design: Treatment, Safety Study
Official Title: Kinetics of Intravenous G-CSF-Induced Granulocyte Mobilization in Healthy Apheresis Donors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 16
Study Start Date: July 1999
Estimated Study Completion Date: June 2002
Detailed Description:

The administration of granulocyte colony-stimulating factor (G-CSF) to increase the white blood cell count in granulocyte donors prior to donation is becoming an increasingly common practice. G-CSF is given subcutaneously to the donor on the day prior to donation, generally 12 to 24 hours before the start of apheresis. It would be advantageous to be able to give G-CSF and collect granulocytes on the same day. However, the single most important factor in optimizing granulocyte collection is the donor's pre-collection granulocyte count. Therefore, any decrease in count would result in a less cellular component. The purpose of this study is to assess granulocyte counts in healthy subjects during an 8-hour period after a single 5 microgram/kg intravenous dose of G-CSF with or without dexamethasone. Sixteen subjects will be studied. Each donor will be studied four separate times. The four mobilization protocols to be studied are G-CSF 5 micrograms/kg given intravenously, G-CSF 5 micrograms/kg subcutaneously, G-CSF 5 micrograms/kg intravenously plus dexamethasone 8 mg orally, and G-CSF 5 micrograms/kg subcutaneously plus dexamethasone 8 mg orally. The order of the route of administration will be assigned randomly. White blood cell counts, neutrophil counts and donor symptoms will be measured before G-CSF administration and at 1/2, 1, 2, 4, 6, 8 and 24 hours after administration. The neutrophil counts measured within the first 8 hours after G-CSF will be compared with counts measured 24 hours after G-CSF.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Male and female subjects.

Must be 18 years of age or older.

Subjects must pass the health criteria for blood donors established by the American Association of Blood Banks.

No subjects who are pregnant or lactating females.

No subjects with uncontrolled hypertension, heart disease, diabetes, history of allergic reactions to G-CSF, history of allergic reactions to E. coli, abnormal hemoglobin or white blood cell counts, a malignancy, asthma, taking prednisone or using an inhalant.

No hemoglobin less than 11.0 or greater than 19.0 gm/dL

No platelet counts less than 140 x 10(9)/L or greater than 500 x 10(9)/L.

No absolute neutrophil count less than 1.5 x 10(9/)/L or greater than 10.0 x 10(9)/L.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001842

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 990141, 99-CC-0141
Study First Received: July 31, 2007
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001842     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Granulocytes
Granulocyte Colony Stimulating Factor
Granulocyte Transfusion Factor
Apheresis
Blood Donors
Healthy Volunteer

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Dexamethasone acetate

ClinicalTrials.gov processed this record on November 05, 2009