Citrate Effects and Bone Density in Long-Term Apheresis Donors

NCT00073060 | Completed

• 2 other identifiers: 04004604-CC-0046
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Apheresis Donors

Keywords

Hypocalcemia; Plateletpheresis; Calcium; Citrate; Bone Density; Natural History; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Citrate Effets on Bone Density

  Determine bone density measurements in serial plateletpheresis and leukapheresis donors \& compare them to bone density measurements in a control group.

  Pre & Post Apheresis

Study Arms (3)

NIH Platelepheresis Donors

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Existing NIH donors@@@@@@

You may qualify if:

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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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• Leonard N Chen, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2003
• First Posted: November 17, 2003
• Study Start: November 17, 2003
• Primary Completion: August 26, 2008
• Study Completion: August 26, 2008
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

US (1)