Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2026-01-08 @ 10:56 AM
Study NCT ID:
NCT06473233
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibrinogen consumption', 'timeFrame': 'up to 24 hours', 'description': 'Quantity of fibrinogen administered (in grams)'}], 'secondaryOutcomes': [{'measure': 'Total number of TEG6S®', 'timeFrame': 'at 12 months', 'description': 'Total number of TEG6S® carried out over a period of 12 months following its implementation'}, {'measure': 'Estimated blood loss', 'timeFrame': 'up to 24 hours', 'description': 'Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials'}, {'measure': 'Calculated blood loss', 'timeFrame': 'up to 24 hours', 'description': 'Estimated total volume of blood loss during PPH, using the following formula = (\\[initial Ht - Ht H24\\] × total blood volume × 100/35) + compensated blood loss (CBL) ; with: total blood volume in milliliters = basis weight × 65 × 1.4, and CBL in milliliters, corresponding to the number of RBC concentrates transfused (1 RBC corresponds to approximately 500 mL of blood at 35% Ht).'}, {'measure': 'Consumption of packed red blood cells (RBC)', 'timeFrame': 'up to 24 hours', 'description': 'Number of packed red blood cells used'}, {'measure': 'Consumption of fresh frozen plasma (FFP)', 'timeFrame': 'up to 24 hours', 'description': 'Number of fresh frozen plasma (FFP) used'}, {'measure': 'Invasive haemostatic procedure', 'timeFrame': 'up to 24 hours', 'description': 'Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy)'}, {'measure': 'Maternal death', 'timeFrame': 'until leaving the hospital', 'description': 'Occurrence of maternal death at hospital'}, {'measure': 'ICU admission', 'timeFrame': 'until leaving the hospital', 'description': 'Any admission in an intensive care unit'}, {'measure': 'ICU length of stay', 'timeFrame': 'until discharge from the intensive care unit', 'description': 'Total length of stay in an intensive care unit/critical care (in days)'}, {'measure': 'Total length of stay', 'timeFrame': 'until discharge from the intensive care unit', 'description': 'Total length of stay in hospital (in days)'}, {'measure': 'Acute anemia', 'timeFrame': 'at 24 hours', 'description': 'Occurrence of anemia following postpartum hemorrhage, defined by a decrease in hemoglobin level of 4g/dL or more at 24h following delivery, compared to the last hemoglobin level known before delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate fibrinogen consumption, transfusion need, and other security outcomes in women with postpartum hemorrhage of 1000 mL or more, before and after the implementation of a TEG6S® device at a level III maternity unit (Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France).', 'detailedDescription': 'Acquired obstetrical coagulopathy during massive postpartum hemorrhage (PPH) is a serious and frequent complication of delivery. It has been shown that fibrinogen levels are the first to fall during PPH, and that a level inferior to a threshold of 2g/L is strongly associated with progression to severe PPH, hemostatic impairment, transfusion, and invasive hemostatic procedures.\n\nThe clinical diagnosis of coagulopathy is difficult, and the biological diagnosis by usual laboratory tests is often delayed, leading to the empirical administration of fibrinogen and blood products, sometimes unnecessary.\n\nThe TEG6S® is a viscoelastic testing device performed on whole blood, which allows a reliable assessment of hemostasis and coagulation quality in about ten minutes.\n\nThe anomalies detected by the TEG6S® allow for the early diagnosis of acquired coagulopathy, especially hypofibrinogenemia. Its use during the management of PPH would therefore allow for transfusion savings and potential economic benefits, in addition to improving patient prognosis through early and appropriate treatment (including the absence of early "blind" treatment in the absence of coagulopathy).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women who gave birth at the level III maternity of Centre Hospitalier Sud Francilien and had postpartum haemorrhage greater than 1000mL or more.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman of 18 years old or more\n* Delivery at the level III maternity of Centre Hospitalier Sud Francilien (CHSF) (Corbeil-Essonnes, France) between 2022 and 2024, except deliveries during cyber-attack period at CHSF (from August 2022 to December 2022 included), due to uncertainty over the completeness of the data.\n* Presenting postpartum hemorrhage with estimated blood loss of 1000mL or more\n* No constitutional hemostasis anomaly\n* No treatment interfering with hemostasis\n* No use of blood products and/or pro-coagulant products before delivery\n\nExclusion Criteria:\n\n\\- Patient informed of the research and refusing the use of the data'}, 'identificationModule': {'nctId': 'NCT06473233', 'acronym': 'INTEGRAL-HPP', 'briefTitle': 'Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage', 'orgStudyIdInfo': {'id': '2024/0013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before TEG6S', 'description': 'Patients managed in a period of 12 months before the implementation of TEG6S®'}, {'label': 'After TEG6S', 'description': 'Patients managed in a period of 12 months after the implementation of TEG6S®', 'interventionNames': ['Device: TEG6S']}], 'interventions': [{'name': 'TEG6S', 'type': 'DEVICE', 'description': 'Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician', 'armGroupLabels': ['After TEG6S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'state': 'France', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}], 'overallOfficials': [{'name': 'Fatima BRIK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}