Stem Cell Related Donor Safety Study (RDSafe)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Center for International Blood and Marrow Transplant Research
Sponsor:
Collaborators:
University of Utah
University of Pittsburgh
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT00948636
First received: July 28, 2009
Last updated: July 3, 2014
Last verified: July 2014

July 28, 2009
July 3, 2014
January 2010
January 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00948636 on ClinicalTrials.gov Archive Site
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Stem Cell Related Donor Safety Study
A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life

The study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unrelated hematopoietic stem cell donors.

The study will also assess the hypothesis that young (<18 years) and older (>60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations.

An ancillary study of the psychological impact of donation on health-related quality of life (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

participating institutions (transplant centers)

Related Hematopoietic Stem Cell Donors
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Related Donors
Related Hematopoietic Stem Cell Donors
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2300
January 2016
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Donors of any age providing either a first or second BM or PBSC donation
  • Meet donation criteria per institution policies and procedures
  • Willing to receive phone follow-up at 1, 6, and 12 months
  • Signed informed consent for study participation

For the HRQoL ancillary study, inclusion criteria:

  • Related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria
  • Donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the HRQoL proxy interview
  • English speaking
  • Access to a telephone
  • Willing to participate in pre-donation, 1 month and 1 year follow-up interviews
  • Signed informed consent for study participation in ancillary study

Exclusion Criteria:

  • Per institutional guidelines
  • Donors providing unstimulated peripheral blood stem cells or lymphocytes

For the HRQoL ancillary study, exclusion criteria:

  • Children less than or equal to 4 years of age
Both
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No
Contact: Hati K Kobusingye, MS 612-294-4385 hkobusin@nmdp.org
Contact: RaeAnne Besser 612-465-7847 rbesser@nmdp.org
United States
 
NCT00948636
06-DON
Yes
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
  • National Institutes of Health (NIH)
  • University of Utah
  • University of Pittsburgh
Principal Investigator: Michael A Pulsipher, M.D. University of Utah
Center for International Blood and Marrow Transplant Research
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP