Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT01938300
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2013-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of maximum clot firmness (MCF) of FIBTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of Clotting time (CT) of INTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of Clot firmness time (CFT) of INTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of Alpha angle of INTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of MCF of INTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of CT of EXTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of CFT of EXTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of Alpha angle of EXTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of MCF of EXTEM', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}], 'secondaryOutcomes': [{'measure': 'Change of Hemoglobin', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of Platelet count', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of International normalized ratio of prothrombin time', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of Activated partial thrombin time', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}, {'measure': 'Change of Fibrinogen', 'timeFrame': '1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day'}]}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients undergoing a laparoscopic colorectal cancer surgery\n\nExclusion Criteria:\n\n* Renal disease\n* Hepatic disease\n* Neuromuscular disease\n* Coagulation disorder\n* Cardiopulmonary disease'}, 'identificationModule': {'nctId': 'NCT01938300', 'briefTitle': 'Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'orgStudyIdInfo': {'id': 'Mg-ROTEM-colorectal ca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium', 'description': 'Magnesium sulfate infusion during a operation period.\n\nInfusion regimen:\n\n1. Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes\n2. Infusion 15 mg/kg/h of magnesium sulfate throughout the operation', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'administration of normal saline as a same volume of magnesium sulphate as a same method.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'armGroupLabels': ['Magnesium']}, {'name': 'Normal saline', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}