Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-04-23 @ 11:35 PM
Study NCT ID:
NCT03276403
Status:
UNKNOWN
Last Update Posted:
2017-09-08
First Post:
2017-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Graft Dysfunction Score in Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-06', 'studyFirstSubmitDate': '2017-09-06', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary graft dysfunction', 'timeFrame': '72 hours after transplantation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a novel PGD score), which can then be tested in future prospective trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving double lung transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic fibrosis (CF), Emphysema\n* No restrictions regarding donor lungs (marginal donors, EVLP possible)\n* No restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations)\n\nExclusion Criteria:\n\n* Single-lung transplantation\n* Heart-lung transplantation\n* Re-transplantation\n* Patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)\n* Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling\n* No access to the femoral artery possible\n* Severe postoperative hemorrhage, which leads to hematothorax and makes revision surgery necessary'}, 'identificationModule': {'nctId': 'NCT03276403', 'briefTitle': 'Primary Graft Dysfunction Score in Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study', 'orgStudyIdInfo': {'id': '1618/2016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PiCCO Catheter', 'type': 'DEVICE', 'description': 'The PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Konrad Hoetzenecker, MD,PhD', 'role': 'CONTACT', 'email': 'konrad.hoetzenecker@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '56990'}, {'name': 'Thomas Schweiger, MD,PhD', 'role': 'CONTACT', 'email': 'thomas.schweiger@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '56990'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Shaf Keshavjee, MD, MSc', 'role': 'CONTACT', 'email': 'shaf.keshavjee@uhn.ca', 'phone': '001416340', 'phoneExt': '3863'}], 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Konrad Hoetzenecker, MD, PhD', 'role': 'CONTACT', 'email': 'konrad.hoetzenecker@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '56990'}, {'name': 'Thomas Schweiger, MD, PhD', 'role': 'CONTACT', 'email': 'thomas.schweiger@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '56990'}], 'overallOfficials': [{'name': 'Konrad Hoetzenecker, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be shared upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc.-Prof. Dr. Konraf Hoetzenecker, PhD', 'investigatorFullName': 'Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}