Identifying Genetic Characteristics That Increase the Risk of Developing Primary Graft Dysfunction Following Lung Transplantation
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Purpose
| Condition |
|---|
|
Primary Graft Dysfunction Lung Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Genetics of Primary Graft Dysfunction |
- Genetic factors that increase the risk of developing PGD [ Time Frame: Measured through the use of genetic samples collected from participants ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 1150 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Undergoing lung transplant surgery
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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: E.J. Demissie, MSN 215-573-4767 edemissi@mail.med.upenn.edu | |
| Principal Investigator: Jason D. Christie, MD | |
| Principal Investigator: | Jason D. Christie, MD | University of Pennsylvania |
More Information
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 |
| Study First Received: | April 5, 2007 |
| Last Updated: | September 9, 2016 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pennsylvania:
|
PGD |
Additional relevant MeSH terms:
|
Primary Graft Dysfunction Reperfusion Injury Vascular Diseases |
Cardiovascular Diseases Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on September 23, 2016