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Status:

COMPLETED

Citrate Effects and Bone Density in Long-Term Apheresis Donors

Lead Sponsor:

National Institutes of Health Clinical Center (CC)

Conditions:

Healthy Apheresis Donors

Eligibility:

All Genders

18-80 years

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 w...

Detailed Description

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 eli...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • \<TAB\>
  • 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.
  • \<TAB\>
  • 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
  • \<TAB\>
  • 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).

Exclusion

    Key Trial Info

    Start Date :

    November 17 2003

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 26 2008

    Estimated Enrollment :

    273 Patients enrolled

    Trial Details

    Trial ID

    NCT00073060

    Start Date

    November 17 2003

    End Date

    August 26 2008

    Last Update

    April 4 2023

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892