Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT04416594
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Acquired FXIII Deficiency on Morbidity and Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cut-Point levels of FXIII', 'timeFrame': '2 years', 'description': 'The investigators aim to find a laboratory parameter, a cut-point plasma level of FXIII, to identify an increased in morbidity and mortality in a mixed cohort of hospitalized patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Factor XIII', 'Blood transfusion', 'Mortality'], 'conditions': ['Acquired Factor XIII Deficiency Disease']}, 'referencesModule': {'references': [{'pmid': '41311329', 'type': 'DERIVED', 'citation': 'Duque P, Esteban ML, Pineiro P, Ortiz-Lopez A, Moreno-Carbonell M, Lancho P, Calvo A, Terradillos E, Pascual-Izquierdo C. Acquired factor XIII deficiency is associated with mortality and is not linked to hypocalcemia. Blood Coagul Fibrinolysis. 2025 Nov 28. doi: 10.1097/MBC.0000000000001400. Online ahead of print.'}, {'pmid': '33851388', 'type': 'DERIVED', 'citation': 'Duque P, Chasco-Ganuza M, Ortuzar A, Almaraz C, Terradillos E, Perez-Rus G, Pascual C. Acquired FXIII Deficiency is Associated with High Morbidity. Thromb Haemost. 2022 Jan;122(1):48-56. doi: 10.1055/a-1481-2733. Epub 2021 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality', 'detailedDescription': 'All patients admitted to a large tertiary hospital with FXIII levels below 70% during their hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity and mortality is registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Medical and surgical hospitalized patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FXIII levels \\< 70%\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04416594', 'briefTitle': 'Impact of Acquired FXIII Deficiency on Morbidity and Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients', 'orgStudyIdInfo': {'id': 'FXIII'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Factor XIII deficiency', 'description': 'Patients admitted to hospital with FXIII levels below 70% during their hospital stay', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Only data collection', 'armGroupLabels': ['Factor XIII deficiency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Gregorio Marañon Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patricia Duque González', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patricia Duque González', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}