NCT00073060

Citrate Effects and Bone Density in Long-Term Apheresis Donors

Completed Last updated 4 April 2023

What this trial tests

trial in Healthy Apheresis Donors in 273 participants. Completed in 26 August 2008.

Timeline

17 November 2003

Primary endpoint
26 August 2008

26 August 2008

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	273
Start date	17 November 2003
Primary completion	26 August 2008
Estimated completion	26 August 2008
Sites	1 location across United States

Conditions studied

• Healthy Apheresis Donors — all drugs for Healthy Apheresis Donors →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 80, any sex, with Healthy Apheresis Donors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Citrate anticoagulation: Are blood donors donating bone?
   Bialkowski W, Bruhn R, Edgren G, Papanek P. · · 2016 · cited 14× · PMID 26607494 · DOI 10.1002/jca.21438