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Stem Cell Related Donor Safety Study (RDSafe)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948636
First Posted: July 29, 2009
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
University of Utah
University of Pittsburgh
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
July 28, 2009
July 29, 2009
June 14, 2017
January 2010
August 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.

Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1812
September 2016
August 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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00948636
06-DON
Yes
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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. Children's Hospital Los Angeles
Center for International Blood and Marrow Transplant Research
July 2016