Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT03449420
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2017-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013916', 'term': 'Thrombelastography'}], 'ancestors': [{'id': 'D001780', 'term': 'Blood Coagulation Tests'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calculated blood loss', 'timeFrame': 'during the 24 hours after delivery', 'description': 'Calculated blood loss at 24 hours after delivery (Sum of the volume of blood transfused and the volume of blood loss calculated by the decrease in hematocrit.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thromboelastography'], 'conditions': ['Post Partum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '31567472', 'type': 'DERIVED', 'citation': 'Rigouzzo A, Louvet N, Favier R, Ore MV, Piana F, Girault L, Farrugia M, Sabourdin N, Constant I. Assessment of Coagulation by Thromboelastography During Ongoing Postpartum Hemorrhage: A Retrospective Cohort Analysis. Anesth Analg. 2020 Feb;130(2):416-425. doi: 10.1213/ANE.0000000000004422.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine if thromboelastography parameters can be predictive of severe post partum hemorrhage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women presenting with a post partum hemorrhage', 'genderDescription': 'pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women presenting with a post partum hemorrhage\n* needing sulprostone infusion\n* during third trimester of pregnancy\n\nExclusion Criteria:\n\n* known coagulation disorders'}, 'identificationModule': {'nctId': 'NCT03449420', 'briefTitle': 'Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Armand Trousseau'}, 'officialTitle': 'Predictability of Thromboelastography Parameters in Severe Post Partum Hemorrhage : a Retrospective Study', 'orgStudyIdInfo': {'id': 'ArmandTrousseau'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post Partum Hemorrhage', 'description': 'Patients presenting with a post partum hemorrhage. A thromboelastography analysis is realized at discretion of the anesthesiologist in charge', 'interventionNames': ['Diagnostic Test: thromboelastography']}], 'interventions': [{'name': 'thromboelastography', 'type': 'DIAGNOSTIC_TEST', 'description': 'TEG5000® : Kaolin and Functional Fibrinogen tests on native blood sample', 'armGroupLabels': ['Post Partum Hemorrhage']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Agnes Rigouzzo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Armand Trousseau'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Armand Trousseau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology Department', 'investigatorFullName': 'Pr Isabelle CONSTANT', 'investigatorAffiliation': 'Hôpital Armand Trousseau'}}}}