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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00531921 |
Activity of genes in donor tissues that are involved in inflammation are thought to be involved with early organ dysfunction, increased immune responses in transplant recipients, and organ rejection. The purpose of this study is to determine the relationship between genetic expression in donor and recipient tissue with transplant survival. Participants in this study will have received heart, lung, liver, or kidney transplants.
Condition |
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Heart Transplantation Kidney Transplantation Liver Transplantation Lung Transplantation |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Correlation of Donor Proinflammatory mRNA Profiles With Early Outcomes of Thoracic and Abdominal Transplantation |
Blood and tissue samples to evaluate the heart, kidney, liver, and lung
Estimated Enrollment: | 450 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Kidney transplant patients from six specific sites
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Liver transplant patients from six specific sites
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Heart transplant patients from six specific sites
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4
Lung transplant patients from six specific sites
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Inflammation and injuries to transplanted organs during the immediate post-operative period may be linked to early organ dysfunction and higher rates of transplant rejection in the recipient. Currently, mRNA expression of proinflammatory genes in donor tissues is thought to be a risk factor for early organ transplant dysfunction, increased expression of the recipients cell-mediated immunity genes, and organ rejection. The purpose of this study is to test the association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in kidney, lung, and liver transplant recipients. This study will also test the effects of proinflammatory mediators expressed in the transplanted organ pre- and post-reperfusion on organ rejection and genes expressed in cell mediated immune responses. This will be achieved by identifying the proinflammatory immune responses and their mechanisms.
This study will consist of up to 11 study visits over a period of 2 years. The baseline visit will occur 24 hours prior to organ transplantation. Follow-up visits will occur daily for Days 1 to 3 (for lung transplant recipients only) and on Day 7, Week 6, and Months 3, 6, 9, 12, 18, and 24 post-transplant. At the baseline visit, a physical exam, medical history, demographics, vital signs measurements, blood collection, and collection of donor tissue sample will occur. For most or all other study visits, medication and adverse events tracking and blood collection will occur. Depending on the transplant type, participants will undergo the following procedures:
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Transplant patients evaluated for the association between proinflammatory mRNA expression from donor samples and subsequent development of early organ dysfunction
Inclusion Criteria for all participants:
Inclusion Criteria for Kidney or Liver Transplant Participants:
Inclusion Criteria for Heart or Lung Transplant Participants:
Exclusion Criteria for All Participants:
Contact: Tina Sledge, RN, BSN | 301-496-3017 | sledget@niaid.nih.gov |
United States, Illinois | |
Northwestern Memorial Hospital (kidney) | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Jane Charette jane-charette@northwestern.edu | |
Principal Investigator: John Friedewald, MD | |
Northwestern Memorial Hospital (liver) | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Jane Charette jane-charette@northwestern.edu | |
Principal Investigator: Mike Abecassis, MD | |
United States, New York | |
Columbia University (lung) | Recruiting |
New York, New York, United States, 10032 | |
Contact: Steven Kawut, MD sk2097@columbia.edu | |
Principal Investigator: Steven Kawut, MD | |
Cornell University Medical College (kidney) | Not yet recruiting |
Ithaca, New York, United States, 14850 | |
Contact: Maria Trantino mat2026@med.cornell.edu | |
Principal Investigator: Darshana Dadhania, MD | |
Columbia University (liver) | Recruiting |
New York, New York, United States, 10032 | |
Contact: Jonathan Kim jk2805@columbia.edu | |
Principal Investigator: Jean Emond, MD | |
United States, Ohio | |
Cleveland Clinic Foundation (heart) | Not yet recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Barbara Gus gusb@ccf.org | |
Principal Investigator: Randall Starling, MD | |
United States, Pennsylvania | |
University of Pennsylvania (heart) | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Mary Kaminski, MD mary.kaminski@uphs.upenn.edu | |
Principal Investigator: Thomas Cappola, MD | |
University of Pennsylvania (lung) | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Mary Kaminski mary.kaminski@uphs.upenn.edu | |
Principal Investigator: Jason Christie, MD | |
University of Pennsylvania (kidney) | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Mary Kaminski mary.kaminski@uphs.upenn.edu | |
Principal Investigator: Alden Doyle, MD | |
University of Pennsylvania (liver) | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Mary Kaminski mary.kaminski@uphs.upenn.edu | |
Principal Investigator: Kim Oltoff, MD | |
United States, Wisconsin | |
University of Wisconsin (heart) | Recruiting |
Madison, Wisconsin, United States, 53706 | |
Contact: Talley Mitchell mmitchell@clinicaltrials.wisc.edu | |
Principal Investigator: Nancy Sweitzer, MD | |
University of Wisconsin (lung) | Recruiting |
Madison, Wisconsin, United States, 53706 | |
Contact: Holly Thomas HThomas@uwhealth.org | |
Principal Investigator: Keith Meyer, MD |
Principal Investigator: | Abraham Shaked, MD, PhD | University of Pennsylvania Medical Center |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT CTOT-03 |
Study First Received: | September 18, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00531921 |
Health Authority: | United States: Federal Government |
Heart Diseases Kidney Diseases Liver Diseases Liver Failure Lung Diseases |
Transplant Transplantation, Homologous Rejection Kidney Failure |
Liver Failure Liver Diseases Heart Diseases |
Lung Diseases Kidney Diseases Kidney Failure |