Cytapheresis of Volunteer Donors
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 24, 2005 | ||||
| Last Updated Date | May 23, 2013 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Mechanism to collect and process components from healthy donors for distribution for in vitro research [ Time Frame: Ongoing ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00104325 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cytapheresis of Volunteer Donors | ||||
| Official Title ICMJE | Cytapheresis of Volunteer Donors | ||||
| Brief Summary | 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). This study is designed to provide white blood cells obtained by Cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies. The subject population consists of healthy males and females 18 years and older. Study subjects are anticipated to be NIA employees, hospital employees, students, and non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will be to maintain 200 active donors. Donors are screened initially and annually by a health history questionnaire and blood and urine tests to detect any obvious blood diseases, bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days. |
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| Detailed Description | 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). This study is designed to provide white blood cells obtained by Cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies. The subject population consists of healthy males and females 18 years and older. Study subjects are anticipated to be NIA employees, hospital employees, students, and non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will be to maintain 200 active donors. Donors are screened initially and annually by a health history questionnaire and blood and urine tests to detect any obvious blood diseases, bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Cytapheresis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE |
After receiving test results, the Principal Investigator or designee completes the On Study Eligibility Form and authorizes eligibility. Study eligibility will be determined in accordance with blood donation guidelines recommended by the AABB and Code of Federal Regulations (CFR). Exclusion Criteria: Significant abnormalities are found on the health history questionnaire or in the results of blood tests. Pregnant or nursing mother. Inadequate venous access for the cell collection procedure. Severe infection in the past two months. On any medication that can alter white blood cell function. A medical finding that shows a participant could not go through this procedure. Unable to provide informed consent. It is less than six weeks since participation in another research study which is felt by the Principal Investigator to be incompatible with this study. Test results are positive for viral infections. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00104325 | ||||
| Other Study ID Numbers ICMJE | 999903316, 03-AG-N316 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ) | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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