NCT Number: NCT00948636
Stem Cell Related Donor Safety Study
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.
Looking for future studies?
Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Banner Good Samaritan Medical Center, Phoenix, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Sponsors and collaborators
Lead sponsor
Center for International Blood and Marrow Transplant Research
Network
Collaborators
- National Institutes of Health (NIH)
- University of Pittsburgh
- University of Utah
Registry information
Official study title
A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
Acronym: RDSafe
Important dates
- Study start
- 2010
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Jul 29, 2009
- Registry last updated
- Jun 14, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.