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NCT00553397 Clinical Trial

Live Lung Donor Retrospective Study

Lung Transplantation Clinical Trial

Official title:
Live Lung Donor Retrospective Study (RELIVE-02)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00553397
Other study ID # DAIT RELIVE-02
Secondary ID RELIVE
Status Completed
Phase N/A
First received November 1, 2007
Last updated March 23, 2017
Start date October 2007
Est. completion date December 2008

Study information
Verified date March 2017
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 369
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Southern California Los Angeles California
United States Washington University Medical Center St. Louis Missouri

Sponsors (3)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Health Resources and Services Administration (HRSA), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View Citation

Bowdish ME, Barr ML. Living lobar lung transplantation. Respir Care Clin N Am. 2004 Dec;10(4):563-79. Review. — View Citation

Goldsmith MF. Mother to child: first living donor lung transplant. JAMA. 1990 Dec 5;264(21):2724. — View Citation

Mallory GB Jr, Cohen AH. Donor considerations in living-related donor lung transplantation. Clin Chest Med. 1997 Jun;18(2):239-44. Review. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Mortality Year 5
Secondary Perioperative morbid events /complications Year 5
Secondary Cause of death Year 5
Secondary Incidence of Donors Requiring Lung Transplantation Incidence of any of the donors who encountered complications related to their donation, which eventually resulted in them receiving lung transplantations. Year 5
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