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Home > "C" Clinical Trials Conditions > Citrate Effects and Bone Density in Long-Term Apheresis Donors  Citrate Effects and Bone Density in Long-Term Apheresis Donors
Citrate Effects and Bone Density in Long-Term Apheresis Donors
For Condition: Blood Component Removal
Status: Recruiting
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: 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.
Details: Approximately one million plateletpheresis procedures are performed each year in the U.S., including 3,500 in the Platelet Center of the Department of Transfusion Medicine, NIH. Healthy donors are eligible to undergo plateletpheresis as often as 24 times per year. During plateletpheresis, citrate anticoagulant is added to the blood collection pathway to prevent clotting in the apheresis device, and is infused into the donor during the procedure.1-3 Adverse effects related to citrate administration are common, and the most well-studied of these is acute hypocalcemia due to the formation of calcium-citrate complexes. Recent studies in our Department indicate that changes in serum calcium, PTH, osteocalcin, alkaline phosphatase, and vitamin D levels are also present and may be sustained for up to 24 hours after apheresis. Observations from European studies suggest that serial plateletpheresis donation may be associated with reduced bone density; however, those studies involved paid donors, who generally are younger and are allowed to donate more frequently than donors in the U.S. In addition to volunteer plateletpheresis donors, the NIH Department of Transfusion Medicine maintains a registry of approximately 500 persons who are wiling to undergo leukapheresis procedures to provide components for in vitro research use, for which they receive compensation. These research apheresis procedures are accomplished using the same devices as plateletpheresis donations, and they also require citrate anticoagulant infusions. However, procedure duration and total dose of citrate administered may be twice as great as that which occurs during plateletpheresis. Leukocyte and plateletpheresis donors may undergo more than 100 apheresis procedures during the course of their participation in the donor program at NIH. Donors are encouraged to take oral calcium carbonate supplements before or during apheresis if citrate related symptoms occur or have occurred in the past. The impact of serial, frequent, long-term apheresis donations on total body calcium balance and bone density are unknown. In this study, we will compare bone density measurements, as assessed by DEXA scans of wrist, lumbosacral spine, hip and entire body in 75 long-term plateletpheresis donors, 75 long-term research leukapheresis donors, and 150 age, gender, and race matched whole blood donors as a control group. Comprehensive laboratory evaluations of the effect of citrate administration on bone metabolism and body calcium and magnesium metabolism before and after apheresis will be performed. The effect of prophylactic oral and intravenous calcium administration on apheresis-induced changes in these laboratory parameters will be assessed. This information will have a major impact on our understanding of the short and long-term adverse effects of citrate administration in committed apheresis donors, and may also provide insight into calcium, magnesium, and phosphorus metabolism.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 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 a 10 year period. 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. 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 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).
Total Enrollment: 300
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040046; 04-CC-0046
Study Start Date: November 13, 2003
Record last reviewed: November 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073060
Other Blood Component Removal Studies:
1. Citrate Effects and Bone Density in Long-Term Apheresis Donors
2. Apheresis Procedures for Research Studies
Related Studies:
Other Blood Component Removal Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Citrate Effects and Bone Density in Long-Term Apheresis Donors
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