- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00073060
Citrate Effects and Bone Density in Long-Term Apheresis Donors
Citrate Effects and Bone Density Studies in Long-Term Apheresis Donors
This study will examine the effects of repeated apheresis procedures on bone density and calcium balance. Apheresis is a procedure for collecting large numbers of a specific blood component, such as white cells (leukapheresis) or platelets (plateletpheresis). For the procedure, whole blood is collected through a needle in an arm vein and is directed through a machine that separates it into its components by spinning. The desired cells are removed and the rest of the blood is returned to the donor, either through the same needle or through a needle in the other arm. A blood thinning medicine called citrate is added to the cell-separating machine. Citrate reduces the ionized calcium levels in the blood, which prevents the blood from clotting. When the blood is returned to the donor, the donor also receives the citrate. This lowers the donor's ionized calcium levels which may irritate nerve and muscle cells, causing tingling around the mouth, hands, and feet during the procedure. The reduced ionized calcium levels result in increased parathyroid hormone levels in the donor, can effect bone calcium stores. In addition, some of the citrate that is returned to the donor is excreted in the urine along with calcium, which causes further loss of calcium from the body. It is not known if the calcium loss during apheresis in people who undergo this procedure repeatedly has any long-term effects on body calcium balance and bone calcium stores. This study will measure bone density and calcium balance in long-term platelet and white cell donors and compare the findings with those of whole blood donors, who do not receive citrate.
Healthy people between 18 and 80 years of age who weigh between 110 and 300 pounds, do not have a metal prosthesis, and are not pregnant may be eligible for this study. Participants undergo the following procedures:
Whole blood donors
- Blood sample collection 2 weeks before blood donation.
- I removed undergo standard whole blood donation
- Urine sample collection.
- DEXA scan to assess bone density by measuring bone calcium stores. For this procedure, the subject lies still on a table while the spine, hip, and whole body are scanned using a small amount of radiation. The forearm is also scanned while the subject is seated. The scan may be repeated after 2 years.
Plateletpheresis and leukapheresis donors
- Standard platelet or white cell donation.
- Blood sample collections immediately prior to and after donation, and on the first, fourth, and fourteenth days after donation.
- Urine sample collections at the beginning and at the end of the apheresis procedure and on the first, fourth, and fourteenth days after the donation.
- DEXA scan at the beginning of the study (no earlier than 2 weeks after their latest apheresis donation). The scan may be repeated after 2 years.
- Some apheresis donors may be asked to have a second procedure in which they take calcium according to standard guidelines for plateletpheresis and leukapheresis. During the second procedure, platelet donors will take oral calcium tablets before starting plateletpheresis. White cell donors will receive calcium intravenously (through a vein) during the second leukapheresis. For this second procedure, the donors provide additional blood and urine samples as described above.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
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Healthy donors who meet all American Association of Blood Banks, Food and Drug Administration and NIH DTM criteria for allogeneic or research blood donation and who have donated blood or apheresis components greater than 50 times in the past 10 years period (NIH donors), greater than 100 times in the past 10 years (non-NIH donors), or less than 25 times in their life (NIH donors).
Age greater than or equal to 18 years and less than or equal to 80 years.
Weight greater than or equal to 50 kg and less than 135 kg.
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Able to give informed consent
Able to donate as early as 08:00 in the morning (apheresis donors only).
EXCLUSION CRITERIA:
Pregnancy
Metal prosthesis in place
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Any prior radiologic contrast administration within preceding one week (includes CT contrast, MRI contrast, intravenous pyelogram, barium swallow or fluoroscopy)
Weight less less than 50 Kg (minimum weight to donate platelets, leukocytes, whole blood)
Weight greater than135 Kg (maximum weight for DEXA Scan)
More than 2 lifetime apheresis donations for whole blood donors (most recent apheresis must be at least one month prior to this study).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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NIH Platelepheresis Donors
75, Apheresis Study Group - donation procedures use same devices as leukapheresis donors, also requiring citrate infusion
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NIH Research Leukapheresis Donors
75, Apheresis Study Group - donation procedures use same devices as plateletpheresis donors, also requiring citrate infusion; citrate administered may be twice as great as during plateletpheresis.
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NIH Whole Blood Donors
150 age, gender, race-matched donors - CONTROL GROUP
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Citrate Effets on Bone Density
Time Frame: Pre & Post Apheresis
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Determine bone density measurements in serial plateletpheresis and leukapheresis donors & compare them to bone density measurements in a control group.
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Pre & Post Apheresis
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 040046
- 04-CC-0046
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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