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Tracking Information | |||||||||||||
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First Received Date † | November 1, 2007 | ||||||||||||
Last Updated Date | September 26, 2008 | ||||||||||||
Start Date † | October 2007 | ||||||||||||
Current Primary Outcome Measures † |
Overall Mortality [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00553397 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Live Lung Donor Retrospective Study | ||||||||||||
Official Title † | Live Lung Donor Retrospective Study | ||||||||||||
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. |
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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. |
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Study Phase | |||||||||||||
Study Type † | Observational | ||||||||||||
Study Design † | Case-Only, Retrospective | ||||||||||||
Condition † | Lung Transplantation | ||||||||||||
Intervention † | |||||||||||||
Study Arms / Comparison Groups | |||||||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Enrollment † | 355 | ||||||||||||
Estimated Completion Date | October 2012 | ||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | Inclusion Criteria:
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Gender | Both | ||||||||||||
Ages | |||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00553397 | ||||||||||||
Responsible Party | Associate Director, Clinical Research Program, DAIT/NIAID | ||||||||||||
Secondary IDs †† | RELIVE | ||||||||||||
Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
Verification Date | June 2007 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |