Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 31, 2007 | ||||
| Last Updated Date | July 14, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Primary graft dysfunction, defined by the ISHLT criteria [ Time Frame: Measured within 72 hours following transplantation ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Levels of protein C and other bleeding and clotting factors, 3-Nitrotyrosine, and protein carbonyls [ Time Frame: Measured 24 hours following lung transplantation ] | ||||
| Change History | Complete list of historical versions of study NCT00552357 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation | ||||
| Official Title ICMJE | Clinical Risk Factors for Primary Graft Dysfunction | ||||
| Brief Summary | Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant. |
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| Detailed Description | 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 PGD is often expensive, and it is the leading cause of death following lung transplantation. Many potential lung donors and recipients are considered unsuitable for lung transplantation because of concern for the development of PGD. Increased levels of chemicals that are involved in bleeding and clotting, including protein C, and certain markers of oxidant stress, which can cause damage to the body's cells and tissues, may increase a person's risk of developing complications following a lung transplant. The purpose of this study is to analyze blood samples to determine if elevated levels of certain chemicals may be associated with an increased risk of developing PGD after lung transplantation. This study will enroll individuals who are undergoing lung or heart and lung transplantation. Blood samples will be collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will also review participants' medical records. There will be no additional study visits. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Blood samples |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | People undergoing lung transplantation |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1150 | ||||
| Estimated Completion Date | October 2012 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 13 Years to 68 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00552357 | ||||
| Other Study ID Numbers ICMJE | 1417, R01 HL087115-01A1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jason Christie, MD, University of Pennsylvania | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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