Citrate Effects and Bone Density in Long-Term Apheresis Donors
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|ClinicalTrials.gov Identifier: NCT00073060|
Recruitment Status : Completed
First Posted : November 17, 2003
Last Update Posted : May 29, 2020
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.
|Condition or disease|
|Healthy Apheresis Donors|
|Study Type :||Observational|
|Actual Enrollment :||273 participants|
|Official Title:||Citrate Effects and Bone Density Studies in Long-Term Apheresis Donors|
|Actual Study Start Date :||November 17, 2003|
75, Apheresis Study Group - donation procedures use same devices as leukapheresis donors, also requiring citrate infusion
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.
NIH Whole Blood Donors
150 age, gender, race-matched donors - CONTROL GROUP
- Citrate Effets on Bone Density [ Time Frame: Pre & Post Apheresis ]Determine bone density measurements in serial plateletpheresis and leukapheresis donors & compare them to bone density measurements in a control group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073060
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Sandhya R Panch, M.D.||National Institutes of Health Clinical Center (CC)|