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Stem Cell Related Donor Safety Study (RDSafe)

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.
 
ClinicalTrials.gov Identifier: NCT00948636
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : June 14, 2017
Sponsor:
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

Study Description
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Brief Summary:

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.


Condition or disease
Related Hematopoietic Stem Cell Donors

Study Design
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Study Type : Observational
Actual Enrollment : 1812 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
Study Start Date : January 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Groups and Cohorts
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Group/Cohort
Related Donors
Related Hematopoietic Stem Cell Donors


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
participating institutions (transplant centers)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948636


Locations
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Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Institutes of Health (NIH)
University of Utah
University of Pittsburgh
Investigators
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Principal Investigator: Michael A Pulsipher, M.D. Children's Hospital Los Angeles
More Information
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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT00948636    
Other Study ID Numbers: 06-DON
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: July 2016