Live Lung Donor Retrospective Study

NCT ID: NCT00553397

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Lung Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Live Lung Donors

Participants had a 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.

No interventions assigned to this group

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Health Resources and Services Administration (HRSA)

FED

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akinlolu Ojo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Washington University Medical Center

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16732172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9723463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11044317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15585183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15268729 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2232048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9187818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1679484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9434686 (View on PubMed)

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.

Reference Type RESULT
PMID: 25039865 (View on PubMed)

Related Links

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https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID) website

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT) website

https://www.nhlbi.nih.gov/

National Heart, Lung, and Blood Institute (NHLBI) website

http://www.hrsa.gov/

Health Resources and Services Administration (HRSA) website

Other Identifiers

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RELIVE

Identifier Type: -

Identifier Source: secondary_id

DAIT RELIVE-02

Identifier Type: -

Identifier Source: org_study_id

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