Living DonorsNCT01742234
RELIVE Informed Consent Study
An observational study of Living Donors and Tissue Donors, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Living Donors, Tissue Donors
- What is being tested?
- Organ Donation
- Type of treatment
- Surgery or procedure
- How many people
- 624 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Nov 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who will be donating at kidney at the University of Minnesota, Mayo Clinic, or University of Alabama or people who will be donating a lung at University of Washington Medical School or the University of Southern California
Who may be able to join
- Living donor of a kidney or lung
Who cannot join
- Unable to give informed consent
About this study
Official title: Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study
An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. However, donating an organ presents health concerns to the donor as well. This study will use surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It will also compare participants' answers across geographic, racial and socio-economic backgrounds.
- Conditions
- Living Donors, Tissue Donors
- Being tested
- Organ Donation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ DonationProcedure or surgery
People in this study will donate either a lung or kidney
| Study group | Role | What they receive |
|---|---|---|
| Kidney Donors | People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama Receives: Procedure: Organ Donation | |
| Lung Donors | People who will donate a lung at the Washington University School of Medicine or the University of Southern California Receives: Procedure: Organ Donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Score 1
Feelings of pressure to donate an organ on a 4-point scale e.g.; "1: No pressure" to "4: A lot of pressure."
Measured: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score 2
Understanding of the donor screening process on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
Measured: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score 3
Understanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
Measured: Change from 1 week prior to donation and 3 months after donation
Secondary outcomes (4)
Questionnaire Score Secondary Endpoint 1
Understanding of short-term medical risks of donation answered on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
Measured: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score Secondary Endpoint 2
Understanding of long-term medical risks of donation expressed by donors on a scale of 1 to 4 e.g.; "1: No understanding" to "4: Full understanding."
Measured: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score Secondary Endpoint 3
Understanding of psychological risks of donation expressed by donors on a scale of 1 to 4 e.g.; "1: No understanding" to "4: Full understanding."
Measured: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score Secondary Endpoint 4
Understanding that recipients may have variable outcomes as expressed by donors on a scale of 1 to 4 e.g.; "1: No understanding" to "4: Full understanding."
Measured: Change from 1 week prior to donation and 3 months after donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startAug 2008
- Primary completionNov 2010
- Study completionNov 2010
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 Living DonorsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Maryam Valapour, MD, Study chair, University of Minnesota, Center for Bioethics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742234
- Sponsor's protocol ID
- DAIT RELIVE 03
- Status last verified
- Mar 2017
- First submitted
- 28 Nov 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
Valapour M, Kahn JP, Bailey RF, Matas AJ. Assessing elements of informed consent among living donors. Clin Transplant. 2011 Mar-Apr;25(2):185-90. doi: 10.1111/j.1399-0012.2010.01374.x. Epub 2010 Dec 16.
PubMed 21158924
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
- Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study
- ClinicalTrials.gov ID
- NCT01742234
- Acronym / sponsor ID
- DAIT RELIVE 03
- Conditions
- Living Donors, Tissue Donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Dec 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.
An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. However, donating an organ presents health concerns to the donor as well. This study will use surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It will also compare participants' answers across geographic, racial and socio-economic backgrounds.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney Donors | – | Procedure: Organ DonationPeople who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama |
| Lung Donors | – | Procedure: Organ DonationPeople who will donate a lung at the Washington University School of Medicine or the University of Southern California |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who will be donating at kidney at the University of Minnesota, Mayo Clinic, or University of Alabama or people who will be donating a lung at University of Washington Medical School or the University of Southern California
Key inclusion criteria (1 listed)
- Living donor of a kidney or lung
Key exclusion criteria (1 listed)
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organ DonationPeople in this study will donate either a lung or kidney | Procedure or surgery | Kidney Donors, Lung Donors |
Primary outcome
Questionnaire Score 1
Time frame: Change from 1 week prior to donation and 3 months after donation
Feelings of pressure to donate an organ on a 4-point scale e.g.; "1: No pressure" to "4: A lot of pressure."
Questionnaire Score 2
Time frame: Change from 1 week prior to donation and 3 months after donation
Understanding of the donor screening process on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
Questionnaire Score 3
Time frame: Change from 1 week prior to donation and 3 months after donation
Understanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
4 secondary outcomes
Questionnaire Score Secondary Endpoint 1
Time frame: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score Secondary Endpoint 2
Time frame: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score Secondary Endpoint 3
Time frame: Change from 1 week prior to donation and 3 months after donation
Questionnaire Score Secondary Endpoint 4
Time frame: Change from 1 week prior to donation and 3 months after donation
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 21158924Valapour M, Kahn JP, Bailey RF, Matas AJ. Assessing elements of informed consent among living donors. Clin Transplant. 2011 Mar-Apr;25(2):185-90. doi: 10.1111/j.1399-0012.2010.01374.x. Epub 2010 Dec 16.
- 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.
Maryam Valapour, MD study chair
University of Minnesota, Center for Bioethics
Questions about this trial
What is this clinical trial studying?
An observational study of Living Donors and Tissue Donors, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 1 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.
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?
Questionnaire Score 1 (time frame: Change from 1 week prior to donation and 3 months after donation). The study lists 3 primary outcomes in all. 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 NCT01742234, 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.