Cytapheresis of Volunteer Donors
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|ClinicalTrials.gov Identifier: NCT00104325|
Recruitment Status : Recruiting
First Posted : February 25, 2005
Last Update Posted : February 21, 2021
|First Submitted Date||February 24, 2005|
|First Posted Date||February 25, 2005|
|Last Update Posted Date||February 21, 2021|
|Actual Study Start Date||January 31, 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Provide white blood cells to National Institute on Aging (NIA) researchers for other in-vitro research studies. [ Time Frame: Indefinite ]
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Cytapheresis of Volunteer Donors|
|Official Title||Cytapheresis of Volunteer Donors|
- National Institute on Aging researchers are looking at studies that require large numbers of white blood cells for lab use. Standard blood samples do not provide enough white blood cells for these studies. Researchers want to use cytapheresis to collect white blood cells from volunteer donors. This procedure can collect larger amounts of white blood cells and reduce the amount of fluid and other cells that are lost.
- To use cytapheresis to collect white blood cells for study.
- Healthy blood donors at least 18 years of age.
Cytapheresis is an automated method/process of cell removal and collection that involves a continuous flow cell separation by centrifugation and the withdrawal of a particular blood component. This allows blood components not collected to be continuously
returned to the donor. Guidance and recommendations for the performance of these procedures are provided in detail in the Standards of the American Association of Blood Banks (AABB) and in the Code of Federal Regulations (CFR).
The study objective is to provide white blood cells obtained by cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies.
The study population consists of healthy males and females 18 years and older. Study subjects are anticipated to be non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will
be 10, 000. This will allow us to try and maintain 200 active participants in this protocol. Volunteers are screened initially and annually by a health history questionnaire and laboratory testing to screen for bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days.
We will collect blood component cells for distribution to NIA research investigators for their studies of the immune system. We will be performing cytapheresis for the collection of 3 7 blood component packs per week. We will need to maintain an active volunteer pool of approximately 200 active volunteers.
|Study Design||Observational Model: Case-Only
Time Perspective: Retrospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
|Study Population||The study population consists of healthy males and females 18 years and older. Study subjects are anticipated to be non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will be 10,000. This will allow us to try and maintain 200 active participants in this protocol. Volunteers are screened initially and annually by a health history questionnaire and laboratory testing to screen for bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days.|
white blood cells obtained through cytapheresis by healthy males and females 18 years and older
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
In addition, eligible participants may not be able to participate in a specific cytapheresis procedure but might be eligible at a later date for:
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999903316
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )|
|Study Sponsor||National Institute on Aging (NIA)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 16, 2021|