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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

Tracking Information
First Submitted Date July 28, 2009
First Posted Date July 29, 2009
Last Update Posted Date June 14, 2017
Study Start Date January 2010
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stem Cell Related Donor Safety Study
Official Title A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population participating institutions (transplant centers)
Condition Related Hematopoietic Stem Cell Donors
Intervention Not Provided
Study Groups/Cohorts Related Donors
Related Hematopoietic Stem Cell Donors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 24, 2016)		 1812
Original Estimated Enrollment
 (submitted: July 28, 2009)		 2300
Actual Study Completion Date September 2016
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00948636
Other Study ID Numbers 06-DON
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Center for International Blood and Marrow Transplant Research
Original Responsible Party Roberta King MPH, Vice President of CIBMTR, National Marrow Donor Program
Current Study Sponsor Center for International Blood and Marrow Transplant Research
Original Study Sponsor Same as current
Collaborators
  • National Institutes of Health (NIH)
  • University of Utah
  • University of Pittsburgh
Investigators
Principal Investigator: Michael A Pulsipher, M.D. Children's Hospital Los Angeles
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date July 2016