Stem Cell Related Donor Safety Study (RDSafe)

Center for International Blood and Marrow Transplant Research (CIBMTR)

Status

Completed

Conditions

Related Hematopoietic Stem Cell Donors

Study type

Observational

Funder types

Other

NETWORK

NIH

Identifiers

NCT00948636

06-DON

Details and patient eligibility

About

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.

Enrollment

1,812 patients

Sex

All

Volunteers

No Healthy Volunteers

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