Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 11:29 AM
Study NCT ID:
NCT02032069
Status:
COMPLETED
Last Update Posted:
2016-03-15
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumoproteins Expression in the Organ Donor
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_WITH_DNA', 'description': 'lung tissues and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-13', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Recipient with primary graft dysfunction', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Graft Dysfunction']}, 'descriptionModule': {'briefSummary': 'Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. We will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Organ donors and lung recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll the organ donors for lung grafts.\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT02032069', 'briefTitle': 'Pneumoproteins Expression in the Organ Donor', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Mont-Godinne'}, 'officialTitle': 'Pneumoproteins Expression in the Organ Donor', 'orgStudyIdInfo': {'id': 'B406201112693'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NHBD', 'description': 'Non Heart Beating Donors', 'interventionNames': ['Other: no intervention']}, {'label': 'BDD', 'description': 'Brain death donors', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'armGroupLabels': ['BDD', 'NHBD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'country': 'Belgium', 'facility': 'CHU Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Mont-Godinne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Asmae Belhaj', 'investigatorAffiliation': 'University Hospital of Mont-Godinne'}}}}