Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT04568694
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2020-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant', 'timeFrame': '72 hours', 'description': 'As defined by International Society of Heart and Lung Transplantation (ISHLT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient is ≥ 18 years old\n* Recipient, or their Legally Authorized Representative is able and willing to sign informed consent\n* Recipient meets standard listing criteria for lung transplantation\n\nExclusion Criteria:\n\n* Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP)\n* Recipient is \\< 18 years old\n* Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation\n* Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study'}, 'identificationModule': {'nctId': 'NCT04568694', 'briefTitle': 'Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-of-Concept Study', 'orgStudyIdInfo': {'id': '20-00339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delayed Lung Transplantation', 'description': 'Patients that received lung(s) delayed for transplantation', 'interventionNames': ['Procedure: Delayed Lung Transplantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Lung Transplantation', 'description': 'Reference Therapy', 'interventionNames': ['Procedure: Conventional Lung Transplantation']}], 'interventions': [{'name': 'Delayed Lung Transplantation', 'type': 'PROCEDURE', 'description': 'Transplants with a planned recipient anesthesia start time between 10:00 pm and 6:00 am will be allowed to move to a start time between 6:00 am and 8:00 am at the earliest. Donor lung(s) cross clamp time must occur between 5:00 pm and 4:00 am. Lungs that meet criteria will be transported in the usual fashion in a cooler of ice at 4oC. Upon arrival to NYULH, the lungs will be transferred to cold static preservation at 10oC within a specific incubator located in a NYULH OR (MYTEMP™65HC, Benchmark Scientific).', 'armGroupLabels': ['Delayed Lung Transplantation']}, {'name': 'Conventional Lung Transplantation', 'type': 'PROCEDURE', 'description': 'Reference Therapy', 'armGroupLabels': ['Conventional Lung Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nader Moazami, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Requests may be directed to the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}