Lung TransplantationNCT01524835
Live Lung Donor Cross-sectional Cohort Study
An observational study of Lung Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This study will gather information on the long-term effects of donating a lung lobe on living donors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplantation
- How many people
- 192 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Live lung donors who participated in transplantation during 1993 through 2006
Who may be able to join
- Donated a lung at University of Southern California or Washington University between January 1, 1993 and December 31, 2006
Who cannot join
- For questionnaire testing: inability to comprehend and complete questionnaires (with assistance)
- For spirometry: self-reported pregnancy, inability to reproducibly perform, and contraindications
- For post-bronchodilator spirometry: allergy to albuterol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Southern California
Los Angeles, California, 90033
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study will gather information on the long-term effects of donating a lung lobe on living donors.
Read the detailed description
Over time, the number of patients on the lung transplant waiting list and the number of lung transplants performed have greatly increased. Unfortunately, the number of patients on the waiting list has outpaced the transplant rate, resulting in a significant number of deaths for patients on the waiting list.
Live lung donation has the potential to decrease wait time for lung transplants and the rate of death for those awaiting transplants. However, since live lung donation typically utilizes one lobe of lung from each of two donors, transplantation puts two donors at risk for adverse events. Although live lung donation began in the early 1990s, there is still a great lack of published and comprehensive, long-term studies, leaving the outcome of live lung donation unclear. This study will assess post-donation outcomes in live lung donors. Specifically, investigators will determine the effects of live lung donation on lung function, quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. Information obtained from this study will allow potential future live lung donors and the interested public to become better informed, and may also assist potential donors in their decision-making process regarding the procedure. Furthermore, positive study results could potentially reassure previous live organ donors about uncertainties concerning their future health.
There will be 369 participants recruited for this study based on live lung donations, which occurred from 1993 through 2006. Study coordinators will contact eligible participants inviting participants to the study and answering any questions. Participants will have the option to partially or completely refuse participation. Each consenting donor will complete a series of questionnaires via phone and mail. The questions address issues related to the donor's quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. The questionnaires will take about one hour to complete. The coordinator will offer assistance regarding questionnaire completion and return. At the end of the study, a final brief status update will be obtained via phone interview.
In addition to questionnaires, participants will also be asked to participate in spirometry testing. For consenting participants, spirometry testing will be scheduled at either the two study sites or an approved Pulmonary Function Laboratory. During the test, the participant will breathe in and out of a plastic tube while a machine measures the amount and flow of air the donor breathes in and out. If deemed appropriate, the participant will do this test again a few minutes after being given albuterol, a drug which aims to optimize lung function. Spirometry testing will last about an hour.
- Conditions
- Lung Transplantation
- Keywords
- Tissue Donors, Lung, Transplants, Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Live lung donors | Live lung donors who participated in donation from 1993 through 2006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometric lung function
Measured: Measured at time of scheduled spirometry testing
Secondary outcomes (7)
Quality of life
Measured: Throughout study
Morbidity
Measured: Throughout study
Psychosocial status, including anxiety and depression symptoms
Measured: Throughout study
Satisfaction with live lung donation
Measured: Throughout study
Decision-making associated with live lung donation
Measured: Throughout study
Representativeness of participating live lung donor study sample
Measured: Throughout study
Predictors of donor outcome and/or status
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Barr, MD, Principal investigator, University of Southern CaliforniaRoger Yusen, MD, MPH, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524835
- Sponsor's protocol ID
- DAIT RELIVE-05
- Status last verified
- Mar 2017
- First submitted
- 31 Jan 2012
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25039865
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Lung Donor Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT01524835
- Acronym / sponsor ID
- DAIT RELIVE-05
- Conditions
- Lung Transplantation
- Keywords
- Tissue Donors, Lung, Transplants, Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will gather information on the long-term effects of donating a lung lobe on living donors.
Detailed description
Over time, the number of patients on the lung transplant waiting list and the number of lung transplants performed have greatly increased. Unfortunately, the number of patients on the waiting list has outpaced the transplant rate, resulting in a significant number of deaths for patients on the waiting list.
Live lung donation has the potential to decrease wait time for lung transplants and the rate of death for those awaiting transplants. However, since live lung donation typically utilizes one lobe of lung from each of two donors, transplantation puts two donors at risk for adverse events. Although live lung donation began in the early 1990s, there is still a great lack of published and comprehensive, long-term studies, leaving the outcome of live lung donation unclear. This study will assess post-donation outcomes in live lung donors. Specifically, investigators will determine the effects of live lung donation on lung function, quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. Information obtained from this study will allow potential future live lung donors and the interested public to become better informed, and may also assist potential donors in their decision-making process regarding the procedure. Furthermore, positive study results could potentially reassure previous live organ donors about uncertainties concerning their future health.
There will be 369 participants recruited for this study based on live lung donations, which occurred from 1993 through 2006. Study coordinators will contact eligible participants inviting participants to the study and answering any questions. Participants will have the option to partially or completely refuse participation. Each consenting donor will complete a series of questionnaires via phone and mail. The questions address issues related to the donor's quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. The questionnaires will take about one hour to complete. The coordinator will offer assistance regarding questionnaire completion and return. At the end of the study, a final brief status update will be obtained via phone interview.
In addition to questionnaires, participants will also be asked to participate in spirometry testing. For consenting participants, spirometry testing will be scheduled at either the two study sites or an approved Pulmonary Function Laboratory. During the test, the participant will breathe in and out of a plastic tube while a machine measures the amount and flow of air the donor breathes in and out. If deemed appropriate, the participant will do this test again a few minutes after being given albuterol, a drug which aims to optimize lung function. Spirometry testing will last about an hour.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live lung donors | – | –Live lung donors who participated in donation from 1993 through 2006 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Live lung donors who participated in transplantation during 1993 through 2006
Key inclusion criteria (1 listed)
- Donated a lung at University of Southern California or Washington University between January 1, 1993 and December 31, 2006
Key exclusion criteria (3 listed)
- For questionnaire testing: inability to comprehend and complete questionnaires (with assistance)
- For spirometry: self-reported pregnancy, inability to reproducibly perform, and contraindications
- For post-bronchodilator spirometry: allergy to albuterol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spirometric lung function
Time frame: Measured at time of scheduled spirometry testing
7 secondary outcomes
Quality of life
Time frame: Throughout study
Morbidity
Time frame: Throughout study
Psychosocial status, including anxiety and depression symptoms
Time frame: Throughout study
Satisfaction with live lung donation
Time frame: Throughout study
Decision-making associated with live lung donation
Time frame: Throughout study
Representativeness of participating live lung donor study sample
Time frame: Throughout study
Predictors of donor outcome and/or status
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Results publication: PubMed 25039865Yusen 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.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Barr, MD principal investigator
University of Southern California
Roger Yusen, MD, MPH study chair
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometric lung function (time frame: Measured at time of scheduled spirometry testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.