Clinical trial NCT00553397: Live Lung Donor Retrospective Study
Official title: Live Lung Donor Retrospective Study (RELIVE-02)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Keywords: Living donor lung transplant
End stage lung disease
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Health Resources and Services Administration (HRSA)
First posted: 2007-11-04
Enrollment: 369
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who have donated a lung at either the University of Southern California or Washington University between 1993 and 2006

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Overall Mortality
timeFrame: Year 5
Secondary outcomes:
measure: Perioperative morbid events /complications
timeFrame: Year 5
measure: Cause of death
timeFrame: Year 5
measure: Incidence of Donors Requiring Lung Transplantation
timeFrame: Year 5
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
Study officials:
affiliation: University of Michigan
name: Akinlolu Ojo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barr ML, Belghiti J, Villamil FG, Pomfret EA, Sutherland DS, Gruessner RW, Langnas AN, Delmonico FL. A report of the Vancouver Forum on the care of the live organ donor: lung, liver, pancreas, and intestine data and medical guidelines. Transplantation. 2006 May 27;81(10):1373-85. doi: 10.1097/01.tp.0000216825.56841.cd. No abstract available.
citation: Barr ML, Schenkel FA, Cohen RG, Barbers RG, Fuller CB, Hagen JA, Wells WJ, Starnes VA. Recipient and donor outcomes in living related and unrelated lobar transplantation. Transplant Proc. 1998 Aug;30(5):2261-3. doi: 10.1016/s0041-1345(98)00612-5. No abstract available.
citation: Battafarano RJ, Anderson RC, Meyers BF, Guthrie TJ, Schuller D, Cooper JD, Patterson GA. Perioperative complications after living donor lobectomy. J Thorac Cardiovasc Surg. 2000 Nov;120(5):909-15. doi: 10.1067/mtc.2000.110685.
citation: Bowdish ME, Barr ML. Living lobar lung transplantation. Respir Care Clin N Am. 2004 Dec;10(4):563-79. doi: 10.1016/j.rcc.2004.06.004.
citation: Bowdish ME, Barr ML, Schenkel FA, Woo MS, Bremner RM, Horn MV, Baker CJ, Barbers RG, Wells WJ, Starnes VA. A decade of living lobar lung transplantation: perioperative complications after 253 donor lobectomies. Am J Transplant. 2004 Aug;4(8):1283-8. doi: 10.1111/j.1600-6143.2004.00514.x.
citation: Goldsmith MF. Mother to child: first living donor lung transplant. JAMA. 1990 Dec 5;264(21):2724. No abstract available.
citation: Mallory GB Jr, Cohen AH. Donor considerations in living-related donor lung transplantation. Clin Chest Med. 1997 Jun;18(2):239-44. doi: 10.1016/s0272-5231(05)70375-0.
citation: Shaw LR, Miller JD, Slutsky AS, Maurer JR, Puskas JD, Patterson GA, Singer PA. Ethics of lung transplantation with live donors. Lancet. 1991 Sep 14;338(8768):678-81. doi: 10.1016/0140-6736(91)91244-o. No abstract available.
citation: Starnes VA, Barr ML, Schenkel FA, Horn MV, Cohen RG, Hagen JA, Wells WJ. Experience with living-donor lobar transplantation for indications other than cystic fibrosis. J Thorac Cardiovasc Surg. 1997 Dec;114(6):917-21; discussion 921-2. doi: 10.1016/S0022-5223(97)70005-9.
citation: Yusen RD, Hong BA, Messersmith EE, Gillespie BW, Lopez BM, Brown KL, Odim J, Merion RM, Barr ML; RELIVE Study Group. Morbidity and mortality of live lung donation: results from the RELIVE study. Am J Transplant. 2014 Aug;14(8):1846-52. doi: 10.1111/ajt.12771.