Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-03 @ 12:59 PM
Study NCT ID:
NCT03156894
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055031', 'term': 'Primary Graft Dysfunction'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective comparison of risk factors (incidence for ordinal and average variables for numerical variables) between patients suffering from severe primary dysfunction of the graft and those not suffering from severe primary dysfunction of the graft', 'timeFrame': '1 month after leaving the operating room'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Graft Dysfunction', 'Primary Graft Dysfunction', 'heart transplant', 'heart failure', 'Hemodynamic parameters', 'Incidence of PDG'], 'conditions': ['Primary Graft Dysfunction']}, 'descriptionModule': {'briefSummary': "Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is secondary in 66% of cases with DPG or multi-organ failure.\n\nThe treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical assistance or ventricular assistance. According to several studies, this could reduce early mortality. Early placement and short-term (\\<30 days) of support appear to improve survival in the first year after transplantation.\n\nThe haemodynamic parameters revealing this DPG are not clearly described in the literature.\n\nhypothesis of this research is that:\n\n* DPG risk factors in strasbourg's hospital center are comparable to other European and international centers.\n* Simple hemodynamic parameters can be used to detect PDG earlier in order to set up assistance more quickly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.\n\nExclusion Criteria:\n\n* multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.'}, 'identificationModule': {'nctId': 'NCT03156894', 'briefTitle': 'Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience', 'orgStudyIdInfo': {'id': '6733'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gharib AJOB, MD', 'role': 'CONTACT', 'email': 'gharib.ajob@chru-strasbourg.fr', 'phone': '33 3 69 54 97 58'}, {'name': 'Alexandre DI MARCO, MD', 'role': 'CONTACT', 'email': 'alexandre.dimarco@chru-strasbourg.fr', 'phone': '33 3 69 55 05 57'}, {'name': 'Gharib AJOB, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexandre DI MARCO, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul-Michel MERTES, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thibaut WIPF, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Réanimation chirurgicale cardio-vasculaire - NHC', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Gharib AJOB, MD', 'role': 'CONTACT', 'email': 'gharib.ajob@chru-strasbourg.fr', 'phone': '33 3 69 54 97 58'}, {'name': 'Alexandre DI MARCO, MD', 'role': 'CONTACT', 'email': 'alexandre.dimarco@chru-strasbourg.fr', 'phone': '33 3 69 55 05 57'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}