Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073060
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2003-11-14
Brief Title:
Citrate Effects and Bone Density in Long-Term Apheresis Donors
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Citrate Effects and Bone Density Studies in Long-Term Apheresis Donors
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 donors 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
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
Detailed Description:
Approximately one million plateletpheresis procedures are performed each year in the US including 3500 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 procedure1-3 Adverse effects related to citrate administration are common the most well-studied 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 did not include a control group and involved paid donors who generally were generally younger allowed to donate more frequently and not representative of the population demographics of the US In addition to volunteer plateletpheresis donors the NIH Department of Transfusion Medicine maintains a registry of approximately 500 persons who undergo leukapheresis procedures to provide components for in vitro research use for which they receive compensation These research apheresis procedures use the same devices as plateletpheresis donations and also require citrate anticoagulant infusions However the 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 The impact of serial frequent long-term apheresis donations on total body calcium balance and bone density are unknown In this study we will measure bone density and laboratory tests in 75 NIH plateletpheresis donors 75 NIH research leukapheresis donors and in a control group of 150 age gender and race matched NIH whole blood donors The apheresis study groups will each include at least 50 frequent donors greater than 50 donations during the past 10 years and 20 donors with less than 25 lifetime donations 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 Similar laboratory and bone density measurements will be performed in 75 subjects who donate platelets at facilities outside of NIH non-NIH donors and who undergo plateletpheresis at more frequent intervals than NIH donors The effect of intravenous calcium administration on apheresis-induced changes in these laboratory parameters will also 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CC-0046 | None | None | None |