Live Lung Donor Retrospective Study

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00553397
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Health Resources and Services Administration (HRSA) (U.S. Fed)
369
2
14
184.5
13.2

Study Details

Study Description

Brief Summary

The use of live donors for solid organ transplantation has increased the number of available organs for those waiting for a transplant. Donation of an organ may have significant effects on a donor's health. This study will determine the baseline characteristics, early postoperative morbidity, and long-term survival for participants who underwent donor lobectomy between 1993 and 2006.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    As the number of patients requiring organ transplants continues to increase, the number of organs available from deceased donors cannot meet demands. Beginning in the early 1990s, organs from living donors became a widely-available option, increasing the number of available organs for transplant. However, because organ donation has the potential to adversely affect a living donor's health, long-term studies to determine the effect of donation on these donors are needed. The purpose of this study is to determine the mortality, the early postoperative morbidity, and the occurrence of end stage lung disease for participants who underwent donor lobectomy between 1993 and 2006. Participants in this study will have had donor lobectomy at the University of Southern California in Los Angeles or the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis.

    There will be no study visits for retrospective cohort study. Investigators will collect data from existing medical records and databases.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    369 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Live Lung Donor Retrospective Study (RELIVE-02)
    Study Start Date :
    Oct 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    Live Lung Donors

    Participants had a living donor lobectomy at one of the two participating study centers, the University of Southern California and the Washington University Medical Center between 1993 and 2006.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Mortality [Year 5]

    Secondary Outcome Measures

    1. Perioperative morbid events /complications [Year 5]

    2. Cause of death [Year 5]

    3. Incidence of Donors Requiring Lung Transplantation [Year 5]

      Incidence of any of the donors who encountered complications related to their donation, which eventually resulted in them receiving lung transplantations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Had living donor lobectomy at one of the two participating study centers, the University of Southern California and the Washington University Medical Center between 1993 and 2006 (inclusive)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California Los Angeles California United States 90033
    2 Washington University Medical Center St. Louis Missouri United States 63110

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)
    • National Heart, Lung, and Blood Institute (NHLBI)
    • Health Resources and Services Administration (HRSA)

    Investigators

    • Principal Investigator: Akinlolu Ojo, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00553397
    Other Study ID Numbers:
    • DAIT RELIVE-02
    • RELIVE
    First Posted:
    Nov 4, 2007
    Last Update Posted:
    Mar 27, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)

    Study Results

    No Results Posted as of Mar 27, 2017