Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001842
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2007-07-31
Brief Title:
G-CSF for Granulocyte Donation
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Kinetics of Intravenous G-CSF-Induced Granulocyte Mobilization in Healthy Apheresis Donors
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 donors 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 microgramkg 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 microgramskg given intravenously G-CSF 5 microgramskg subcutaneously G-CSF 5 microgramskg intravenously plus dexamethasone 8 mg orally and G-CSF 5 microgramskg 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 12 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-CC-0141 | None | None | None |