Stem Cell Related Donor Safety Study (RDSafe)
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Purpose
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 |
|---|
|
Related Hematopoietic Stem Cell Donors |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life |
| Estimated Enrollment: | 2300 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Related Donors
Related Hematopoietic Stem Cell Donors
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
participating institutions (transplant centers)
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| Contact: Amy E Hays, MPH | 612-884-8559 | ahays@nmdp.org |
| Contact: Hati Kobusingye, MS | 612-294-8345 | hkobusin@nmdp.org |
Show 52 Study Locations| Principal Investigator: | Michael A Pulsipher, M.D. | University of Utah |
More Information
No publications provided
| Responsible Party: | Center for International Blood and Marrow Transplant Research |
| ClinicalTrials.gov Identifier: | NCT00948636 History of Changes |
| Other Study ID Numbers: | 06-DON |
| Study First Received: | July 28, 2009 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 13, 2013