Live Lung Donor Retrospective Study
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|
|
Lung Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Live Lung Donor Retrospective Study |
- Overall Mortality [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Perioperative morbid events /complications [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Cause of death [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Lung transplantation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 355 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adults who have donated a lung at either the University of Southern California or Washington University between 1993 and 2006
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| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, Missouri | |
| Washington University Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Akinlolu Ojo, MD | University of Michigan |
More Information
Publications:
| Responsible Party: | Associate Director, Clinical Research Program, DAIT/NIAID |
| ClinicalTrials.gov Identifier: | NCT00553397 History of Changes |
| Other Study ID Numbers: | DAIT RELIVE-02, RELIVE |
| Study First Received: | November 1, 2007 |
| Last Updated: | October 13, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Living donor lung transplant End stage lung disease |
ClinicalTrials.gov processed this record on May 23, 2013