Identifying Genetic Characteristics That Increase the Risk of Developing Primary Graft Dysfunction Following Lung Transplantation
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| ClinicalTrials.gov Identifier: NCT00457847 |
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Recruitment Status :
Recruiting
First Posted : April 9, 2007
Last Update Posted : July 11, 2017
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| Condition or disease |
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| Primary Graft Dysfunction Lung Transplantation |
PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for this condition is often expensive, and it is the leading cause of death following lung transplant. Many potential donors and recipients are considered unsuitable for lung transplant because of concern for the development of PGD. Therefore, the ability to accurately predict which individuals are at risk for developing PGD may allow more lung transplants to be performed. Specific characteristics in both lung donors and recipients may play an important role in determining the risk of PGD. For example, genetic variations in how the body deals with harmful chemicals called oxidants may be associated with the development of PGD. The purpose of this study is to identify the specific genetic biomarkers in donors and recipients that put individuals at risk for developing PGD following a lung transplant.
This study will enroll individuals who are undergoing lung transplantation. Blood samples will be collected from lung donors and from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will monitor participants for 72 hours following surgery for symptoms of PGD. There will be no additional study visits.
| Study Type : | Observational |
| Estimated Enrollment : | 1150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Genetics of Primary Graft Dysfunction |
| Study Start Date : | February 2007 |
| Estimated Primary Completion Date : | June 2018 |
| Estimated Study Completion Date : | June 2018 |
- Genetic factors that increase the risk of developing PGD [ Time Frame: Measured through the use of genetic samples collected from participants ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Undergoing lung transplant surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457847
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jason D. Christie, MD 215-573-3209 jchristi@mail.med.upenn.edu | |
| Contact: Michelle Oyster, MS 215-573-4767 oysterm@mail.med.upenn.edu | |
| Principal Investigator: Jason D. Christie, MD | |
| Principal Investigator: | Jason D. Christie, MD | University of Pennsylvania |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00457847 History of Changes |
| Other Study ID Numbers: |
1380 R01HL081619 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 9, 2007 Key Record Dates |
| Last Update Posted: | July 11, 2017 |
| Last Verified: | July 2017 |
Keywords provided by University of Pennsylvania:
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PGD |
Additional relevant MeSH terms:
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Primary Graft Dysfunction Reperfusion Injury Vascular Diseases |
Cardiovascular Diseases Postoperative Complications Pathologic Processes |