Live Lung Donor Retrospective Study - Full Text View

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

MedlinePlus related topics:

Lung Transplantation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective

Official Title:	Live Lung Donor Retrospective Study

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Overall Mortality [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	355
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2012

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

adults who have donated a lung at either the University of Southern California or Washington University

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 and Barnes-Jewish Hospital in St. Louis between 1993 and 2006 (inclusive)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553397

Locations


United States, California
	University of Southern California
	Los Angeles, California, United States, 90033

United States, Missouri
	Washington University Medical Center and Barnes-Jewish Hospital
	St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Health Resources and Services Administration (HRSA)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Roger D. Yusen, MD, MPH	School of Medicine, Washington University at St. Louis

Principal Investigator:	Mark Barr, MD	University of Southern California

Principal Investigator:	Barry Hong, PhD	Washington University School of Medicine, St. Louis

More Information

Publications:

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. No abstract available.

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. No abstract available.

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.

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

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.

Goldsmith MF. Mother to child: first living donor lung transplant. JAMA. 1990 Dec 5;264(21):2724. No abstract available.

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

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. No abstract available.

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.

Responsible Party:	DAIT/NIAID ( Associate Director, Clinical Research Program )
Study ID Numbers:	DAIT RELIVE-02, RELIVE
First Received:	November 1, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00553397
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

Study placed in the following topic categories:

Lung Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Health Resources and Services Administration (HRSA) National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00553397