Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-03-28 @ 7:59 AM
Study NCT ID:
NCT01889732
Status:
UNKNOWN
Last Update Posted:
2013-06-28
First Post:
2013-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-26', 'studyFirstSubmitDate': '2013-06-20', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early postoperative bleeding(chest tube drainage)', 'timeFrame': 'postoperative bleeding during 6hrs.', 'description': 'primary outcome is Chest tube drainage(blood volume) during 6hrs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Other Functional Disturbances Following Cardiac Surgery', 'Postoperative Hemorrhage', 'Coagulation Defect; Bleeding']}, 'descriptionModule': {'briefSummary': 'Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. In this retrospective study, the investigators will compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'elective cardiac surgical patient age 20-80years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac surgical patients using Cardiopulmonary bypass\n\nExclusion Criteria:\n\n* known coagulation disorder\n* Using deep hypothermic circulatory arrest\n* Using partial cardiopulmonary bypass'}, 'identificationModule': {'nctId': 'NCT01889732', 'briefTitle': 'A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Effectiveness Evaluation of Rotational Thromboelastometry(ROTEM) for Predicting Postoperative Bleeding in Cardiac Surgical Patients Using a Gray Zone Approach : A Preliminary Retrospective Study', 'orgStudyIdInfo': {'id': 'SMC 2013-05-060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ROTEM', 'interventionNames': ['Device: ROTEM']}], 'interventions': [{'name': 'ROTEM', 'type': 'DEVICE', 'armGroupLabels': ['ROTEM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jonghwan lee, MD,PhD', 'role': 'CONTACT', 'email': 'jonghwan75.lee@samsung.com', 'phone': '82-2-3410-1928'}, {'name': 'Eunhee Kim, MD', 'role': 'CONTACT', 'email': 'eunhee0720.kim@samsung.com', 'phone': '82-2-3410-2470'}, {'name': 'Jonghwan Lee, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eunhee Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'jonghwan lee, MD,PhD', 'role': 'CONTACT', 'email': 'jonghwan75.lee@samsung.com', 'phone': '82-2-3410-1928'}, {'name': 'eunhee kim, MD', 'role': 'CONTACT', 'email': 'eunhee0720.kim@samsung.com', 'phone': '82-2-3410-2470'}], 'overallOfficials': [{'name': 'jonghwan lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'eunhee kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}