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. Identifier: NCT00948636
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : June 14, 2017
National Institutes of Health (NIH)
University of Utah
University of Pittsburgh
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

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 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

Related Donors
Related Hematopoietic Stem Cell Donors

Information from the National Library of Medicine

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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)

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

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 identifier (NCT number): NCT00948636

  Hide Study Locations
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, California
University of California, San Diego
San Diego, California, United States, 92093
University of California, San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Florida Center for Cellular Therapy
Orlando, Florida, United States, 32804
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Children's Memorial Medical Center
Chicago, Illinois, United States, 60014
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana Blood and Marrow Transplantation, LLC
Beech Grove, Indiana, United States, 46107
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Helen DeVos Children's Hospital - Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39095
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Washington University
Saint Louis, Missouri, United States, 63110
United States, New Jersey
John Theurer Cancer Center - Hackensack University Medcial Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
North Shore University Hospital
Lake Success, New York, United States, 11042
Cohen Children's Medical Center of NY
New Hyde Park, New York, United States, 11040
Mt. Sinai Medical Center
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27705
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Jewish Hospital
Cincinnati, Ohio, United States, 45236
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Institute of Medicine and Surgery
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah, Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
University of Utah
Salt Lake City, Utah, United States, 84113
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
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

Responsible Party: Center for International Blood and Marrow Transplant Research Identifier: NCT00948636     History of Changes
Other Study ID Numbers: 06-DON
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: July 2016