Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-01-04 @ 4:44 AM
Study NCT ID:
NCT05149261
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulopathy in Acute Aortic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Routine care blood samples will be taken at different moments of the hospital stay'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total transfusion requirements', 'timeFrame': 'Day 2', 'description': 'red blood cells units (number)'}, {'measure': 'death from AAS', 'timeFrame': 'Day 30', 'description': 'probability of Survival (pourcentage %)'}, {'measure': 'coagulopathy rTQ > 1.2 incidence', 'timeFrame': 'baseline', 'description': 'pourcentage %'}], 'secondaryOutcomes': [{'measure': 'total transfusion requirements', 'timeFrame': 'Day 1', 'description': 'red blood cell unit, fresh frozen plasma and platelets units (number)'}, {'measure': 'total transfusion requirements', 'timeFrame': 'Day 2', 'description': 'red blood cell unit, fresh frozen plasma and platelets units (number)'}, {'measure': 'total transfusion requirements', 'timeFrame': 'Day 3', 'description': 'red blood cell unit, fresh frozen plasma and platelets units'}, {'measure': 'total transfusion requirements', 'timeFrame': 'Day 7', 'description': 'red blood cell unit, fresh frozen plasma and platelets units'}, {'measure': 'biological AAS coagulopathy : coagulation factors consumption', 'timeFrame': 'Day 1, Day 2, Day 3, Day 7', 'description': 'pourcentage %'}, {'measure': 'biological AAS coagulopathy : coagulation factors consumption', 'timeFrame': 'Day 2', 'description': 'pourcentage %'}, {'measure': 'biological AAS coagulopathy : coagulation factors consumption', 'timeFrame': 'Day 3', 'description': 'pourcentage %'}, {'measure': 'biological AAS coagulopathy : coagulation factors consumption', 'timeFrame': 'Day 7', 'description': 'pourcentage %'}, {'measure': 'biological AAS coagulopathy : fibrinolysis D-dimers', 'timeFrame': 'Day 1', 'description': 'µg/L'}, {'measure': 'biological AAS coagulopathy : fibrinolysis D-dimers', 'timeFrame': 'Day 2', 'description': 'µg/L'}, {'measure': 'biological AAS coagulopathy : fibrinolysis D-dimers', 'timeFrame': 'Day 3', 'description': 'µg/L'}, {'measure': 'biological AAS coagulopathy : fibrinolysis D-dimers', 'timeFrame': 'Day 7', 'description': 'µg/L'}, {'measure': 'hospitalisation duration', 'timeFrame': 'hospital discharge', 'description': 'number of days'}, {'measure': 'impact of misdiagnosis and misdiagnosis-induced treatments', 'timeFrame': 'Day 2', 'description': 'massive post-operative bleeding (BART definition)'}, {'measure': 'impact of misdiagnosis and misdiagnosis-induced treatments', 'timeFrame': 'Day 7', 'description': 'massive post-operative bleeding (BART definition)'}, {'measure': 'platelets dysfunction', 'timeFrame': 'day 1', 'description': 'platelets rate G/L'}, {'measure': 'platelets dysfunction', 'timeFrame': 'day 2', 'description': 'platelets rate G/L'}, {'measure': 'platelets dysfunction', 'timeFrame': 'day 3', 'description': 'platelets rate G/L'}, {'measure': 'platelets dysfunction', 'timeFrame': 'day 7', 'description': 'platelets rate G/L'}, {'measure': 'platelets dysfunction', 'timeFrame': 'baseline', 'description': 'CD 40 L pg/mL'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'IL6 rate pg/mL'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'IL8 rate pg/mL'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'syndecan rate pg/mL'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'endocan rate pg/mL'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'angiopoietine 2 rate ng/mL'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'angiopoietine 2 / angiopoietine 2 ratio'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'VEGF ng/mL'}, {'measure': 'endotheliopathy', 'timeFrame': 'baseline', 'description': 'FGF basic ng/mL'}, {'measure': 'symptoms-surgery delay', 'timeFrame': 'baseline', 'description': 'time hours'}, {'measure': 'clinical severity shock', 'timeFrame': 'baseline', 'description': 'acidosis pH'}, {'measure': 'clinical severity shock', 'timeFrame': 'baseline', 'description': 'lactate level (mmol/L)'}, {'measure': 'clinical severity shock', 'timeFrame': 'baseline', 'description': 'number of organs with malperfusion (number)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coagulopathy', 'Acute aortic dissection', 'Blood transfusion'], 'conditions': ['Coagulopathy']}, 'descriptionModule': {'briefSummary': 'The existence of AAS coagulopathy has been reported, related to blood contact with the walls of the non-endothelialized false lumens. It is likely that endothelial dysfunction generated by vascular lesions may largely contribute to the development of coagulopathy, such as described in trauma-induced coagulopathy. This endotheliopathy of the AAS has never been evaluated. The coagulopathy of AAS and more specifically the endotheliopathy are poorly described and therefore have no standardized treatment.\n\nThe main objective of this study is to describe the coagulopathy', 'detailedDescription': 'Acute aortic syndromes (AAS) result from an organic lesion of the aortic wall. The various symptoms of AAS, mainly the acute chest pain, leads to a breakdown of the intima or the media of the aorta. This syndrome is made of three entities : aortic dissection (DA), intra-mural hematoma (HIM) and penetrating atherosclerotic ulcer (PAU). Surgery is a complex emergency treatment of choice. Patients suffering from these pathologies die mainly from hemorrhagic shock due to haemostasis disorders, which requires massive transfusion. The existence of AAS coagulopathy has been reported, related to blood contact with the walls of the non-endothelialized false lumens. It is likely that endothelial dysfunction generated by vascular lesions may largely contribute to the development of coagulopathy, such as described in trauma-induced coagulopathy. This endotheliopathy of the AAS has never been evaluated. The coagulopathy of AAS and more specifically the endotheliopathy are poorly described and therefore have no standardized treatment.\n\nThe main objective of this study is to describe the coagulopathy and more specifically the endotheliopathy of AAS, in particular assessing coagulation disorders, hyperactivation of fibrinolysis, quantitative or functional platelets disorder and endotheliopathy. The secondary objective is to determine the factors associated with this coagulopathy. This includes 1 / assessment of potential risk factors for coagulopathy, 2 / the prognosis of coagulopathy by assessing the relationship between coagulopathy and transfusion requirements and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The EGPH offers, since 2009, a multidisciplinary network called "SOS Aorta" to centralize clinico-radiological suspicions of acute aortic syndrome in Ile de France and provide responsive and accessible medico-surgical care permanently. We included prospectively and analysed retrospectively (descripive study) all patient aged more than 18y who were admitted at EGPH for AAS suspicion via SOS Aorta Network.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to hospital via the "SOS Aorta" network for acute aortic syndrome (AAS) suspicion\n\nExclusion Criteria:\n\n* aged \\< 18y\n* pregnant women\n* no social security'}, 'identificationModule': {'nctId': 'NCT05149261', 'acronym': 'SAACAOG', 'briefTitle': 'Coagulopathy in Acute Aortic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'European Georges Pompidou Hospital'}, 'officialTitle': 'Coagulopathy in Acute Aortic Syndrome', 'orgStudyIdInfo': {'id': 'SAACOAG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute aortic syndrome', 'description': 'patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Godier, MD-PhD', 'role': 'CONTACT', 'email': 'anne.godier@aphp.fr', 'phone': '+33156092584'}], 'facility': 'Université de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Diane Zlotnik, MD', 'role': 'CONTACT', 'email': 'diane.zlotnik@aphp.fr', 'phone': '+33156092428'}, {'name': 'Anne Godier, MD-PhD', 'role': 'CONTACT', 'email': 'anne.godier@aphp.fr', 'phone': '+33156092584'}], 'overallOfficials': [{'name': 'Diane Zlotnik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Georges Pompidou Hospital'}, {'name': 'Anne Godier, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'European Georges Pompidou Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'we will maybe try later to make a multicentric descriptive analysis with other french hospitals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Georges Pompidou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diane Zlotnik', 'investigatorAffiliation': 'European Georges Pompidou Hospital'}}}}