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Live Lung Donor Retrospective Study

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00553397
First received: November 1, 2007
Last updated: March 23, 2017
Last verified: March 2017
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Live Lung Donor Retrospective Study (RELIVE-02)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall Mortality [ Time Frame: Year 5 ]

Secondary Outcome Measures:
  • Perioperative morbid events /complications [ Time Frame: Year 5 ]
  • Cause of death [ Time Frame: Year 5 ]
  • Incidence of Donors Requiring Lung Transplantation [ Time Frame: Year 5 ]
    Incidence of any of the donors who encountered complications related to their donation, which eventually resulted in them receiving lung transplantations.


Enrollment: 369
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 between 1993 and 2006
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Heart, Lung, and Blood Institute (NHLBI)
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Akinlolu Ojo, MD University of Michigan
  More Information

Additional Information:
Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY293
ImmPort study identifier is SDY293
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY293
ImmPort study identifier is SDY293. The study protocol is available in the Design tab section.
Study summary, -design, -demographics, -files  This link exits the ClinicalTrials.gov site
Identifier: SDY293
ImmPort study identifier is SDY293

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00553397     History of Changes
Other Study ID Numbers: DAIT RELIVE-02
RELIVE
Study First Received: November 1, 2007
Last Updated: March 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Living donor lung transplant
End stage lung disease

ClinicalTrials.gov processed this record on August 18, 2017