RELIVE Informed Consent Study

NCT ID: NCT01742234

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

624 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Living Donors Tissue Donors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Kidney Donors

People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama

Organ Donation

Intervention Type PROCEDURE

People in this study will donate either a lung or kidney

Lung Donors

People who will donate a lung at the Washington University School of Medicine or the University of Southern California

Organ Donation

Intervention Type PROCEDURE

People in this study will donate either a lung or kidney

Interventions

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Organ Donation

People in this study will donate either a lung or kidney

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Living donor of a kidney or lung

Exclusion Criteria

* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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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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Maryam Valapour, MD

Role: STUDY_CHAIR

University of Minnesota, Center for Bioethics

References

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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.

Reference Type RESULT
PMID: 21158924 (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

Other Identifiers

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DAIT RELIVE 03

Identifier Type: -

Identifier Source: org_study_id

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