NCT00553397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

November 1, 2007

Last Update Submit

March 23, 2017

Conditions

Keywords

Living donor lung transplantEnd stage lung disease

Outcome Measures

Primary Outcomes (1)

  • Overall Mortality

    Year 5

Secondary Outcomes (3)

  • Perioperative morbid events /complications

    Year 5

  • Cause of death

    Year 5

  • Incidence of Donors Requiring Lung Transplantation

    Year 5

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults who have donated a lung at either the University of Southern California or Washington University between 1993 and 2006

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Related 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. doi: 10.1097/01.tp.0000216825.56841.cd. No abstract available.

    PMID: 16732172BACKGROUND
  • 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.

    PMID: 9723463BACKGROUND
  • 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.

    PMID: 11044317BACKGROUND
  • 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.

    PMID: 15585183BACKGROUND
  • 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.

    PMID: 15268729BACKGROUND
  • Goldsmith MF. Mother to child: first living donor lung transplant. JAMA. 1990 Dec 5;264(21):2724. No abstract available.

    PMID: 2232048BACKGROUND
  • 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.

    PMID: 9187818BACKGROUND
  • 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.

    PMID: 1679484BACKGROUND
  • 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.

    PMID: 9434686BACKGROUND
  • 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.

Related Links

Study Officials

  • Akinlolu Ojo, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2007

First Posted

November 5, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Available IPD Datasets

Individual Participant Data Set (SDY293)Access
Study Protocol (SDY293)Access
Study summary, -design, -demographics, -files (SDY293)Access

Locations