Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-29 @ 11:00 AM
Study NCT ID:
NCT00767832
Status:
COMPLETED
Last Update Posted:
2009-11-09
First Post:
2008-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Venous blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-06', 'studyFirstSubmitDate': '2008-10-03', 'studyFirstSubmitQcDate': '2008-10-06', 'lastUpdatePostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)', 'timeFrame': 'pre and post cesarean delivery'}], 'secondaryOutcomes': [{'measure': 'Hematologic indices'}]}, 'conditionsModule': {'conditions': ['Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '21474664', 'type': 'DERIVED', 'citation': 'Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.', 'detailedDescription': 'The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy pregnant patients undergoing elective cesarean delivery with spinal anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Hospital who undergo elective Cesarean delivery.\n* We will select 100 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective Cesarean delivery, with no anticipated risk of obstetric hemorrhage.\n\nExclusion Criteria:\n\n* Patients with underlying coagulation disorders.\n* Patients with thrombocytopenia.\n* Patients with pregnancy-induced hypertension, pre-eclampsia.\n* Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.\n* Patients requiring non-elective Cesarean delivery.\n* Patients with significant obstetric or medical disease.\n* No patients \\<18 years of age will be recruited.'}, 'identificationModule': {'nctId': 'NCT00767832', 'briefTitle': 'Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.', 'orgStudyIdInfo': {'id': 'SU-08252008-1287'}, 'secondaryIdInfos': [{'id': '11914'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Alexander J Butwick', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Alex James Butwick', 'oldOrganization': 'Stanford University School of Medicine'}}}}