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Completed

NCT Number: NCT00553397

Live Lung Donor Retrospective Study

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.

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Key information

Conditions

Lung Transplantation

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Southern California, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Overall Mortality

    Time frame: Year 5

Secondary outcomes

  1. Perioperative morbid events /complications

    Time frame: Year 5

  2. Cause of death

    Time frame: Year 5

  3. Incidence of Donors Requiring Lung Transplantation

    Time frame: Year 5

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

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Health Resources and Services Administration (HRSA)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Live Lung Donor Retrospective Study (RELIVE-02)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 5, 2007
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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