Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-04-05 @ 11:43 PM
Study NCT ID:
NCT00552357
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2007-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055031', 'term': 'Primary Graft Dysfunction'}], 'ancestors': [{'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2007-10-31', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary graft dysfunction, defined by the ISHLT criteria', 'timeFrame': 'Measured within 72 hours following transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Graft Dysfunction', 'Lung Transplantation']}, 'referencesModule': {'references': [{'pmid': '37734031', 'type': 'DERIVED', 'citation': 'Diamond JM, Cantu E, Calfee CS, Anderson MR, Clausen ES, Shashaty MGS, Courtwright AM, Kalman L, Oyster M, Crespo MM, Bermudez CA, Benvenuto L, Palmer SM, Snyder LD, Hartwig MG, Todd JL, Wille K, Hage C, McDyer JF, Merlo CA, Shah PD, Orens JB, Dhillon GS, Weinacker AB, Lama VN, Patel MG, Singer JP, Hsu J, Localio AR, Christie JD. The Impact of Donor Smoking on Primary Graft Dysfunction and Mortality after Lung Transplantation. Am J Respir Crit Care Med. 2024 Jan 1;209(1):91-100. doi: 10.1164/rccm.202303-0358OC.'}, {'pmid': '23306540', 'type': 'DERIVED', 'citation': 'Diamond JM, Lee JC, Kawut SM, Shah RJ, Localio AR, Bellamy SL, Lederer DJ, Cantu E, Kohl BA, Lama VN, Bhorade SM, Crespo M, Demissie E, Sonett J, Wille K, Orens J, Shah AS, Weinacker A, Arcasoy S, Shah PD, Wilkes DS, Ware LB, Palmer SM, Christie JD; Lung Transplant Outcomes Group. Clinical risk factors for primary graft dysfunction after lung transplantation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):527-34. doi: 10.1164/rccm.201210-1865OC. Epub 2013 Jan 10.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People undergoing lung transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing lung or combined heart and lung transplantation\n\nExclusion Criteria:\n\n* Undergoing combined organ transplantation other than heart and lung transplantation'}, 'identificationModule': {'nctId': 'NCT00552357', 'briefTitle': 'Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Clinical Risk Factors for Primary Graft Dysfunction', 'orgStudyIdInfo': {'id': '1417'}, 'secondaryIdInfos': [{'id': 'R01HL087115-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01HL087115-01A1', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'E.J. Demissie, MSN', 'role': 'CONTACT', 'phone': '215-573-4767'}], 'overallOfficials': [{'name': 'Jason D. Christie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Vanderbilt University', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}