Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT02484157
Status:
COMPLETED
Last Update Posted:
2015-06-29
First Post:
2015-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of ACT Between Hemochron Jr and ACT Plus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-26', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of activated coagulation time between Hemochron Jr and ACT Plus', 'timeFrame': 'During cardiac surgeris (within 8 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Whole Blood Coagulation Time', 'cardiac surgery'], 'conditions': ['Cardiac Disease']}, 'referencesModule': {'references': [{'pmid': '15506033', 'type': 'BACKGROUND', 'citation': 'Svenmarker S, Appelblad M, Jansson E, Haggmark S. Measurement of the activated clotting time during cardiopulmonary bypass: differences between Hemotec ACT and Hemochron Jr apparatus. Perfusion. 2004;19(5):289-94. doi: 10.1191/0267659104pf755oa.'}, {'pmid': '19277416', 'type': 'BACKGROUND', 'citation': 'Chia S, Van Cott EM, Raffel OC, Jang IK. Comparison of activated clotting times obtained using Hemochron and Medtronic analysers in patients receiving anti-thrombin therapy during cardiac catheterisation. Thromb Haemost. 2009 Mar;101(3):535-40.'}, {'pmid': '22534410', 'type': 'BACKGROUND', 'citation': 'Bosch YP, Weerwind PW, Nelemans PJ, Maessen JG, Mochtar B. An evaluation of factors affecting activated coagulation time. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):563-8. doi: 10.1053/j.jvca.2012.03.011. Epub 2012 Apr 24.'}, {'pmid': '16548858', 'type': 'BACKGROUND', 'citation': 'Dalbert S, Ganter MT, Furrer L, Klaghofer R, Zollinger A, Hofer CK. Effects of heparin, haemodilution and aprotinin on kaolin-based activated clotting time: in vitro comparison of two different point of care devices. Acta Anaesthesiol Scand. 2006 Apr;50(4):461-8. doi: 10.1111/j.1399-6576.2006.00990.x.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus).', 'detailedDescription': "Measurement of activated clotting time (ACT) is a standard method for anticoagulation monitoring. Especially in cardiac surgery, heparin is usually used as anticoagulant and protamine is used to reverse anticoagulation effect at the end of surgery. ACT method defines the time until a clot is formed in a test tube after triggering of internal pathway coagulation using blood activating agents (eg. kaolin).\n\nAcute normovolemic hemodilution (ANH) consists of withdrawing patient's blood volume early in the operative period and concurrent infusion of crystalloid or colloid to maintain intravascular volume, and is used in cardiac surgery. ANH is known to affect hemostasis in some studies.\n\nAssuming that accurate monitoring of coagulation therapy is important to prevent both thrombotic and hemorrhagic complications, we compared ACT results from 2 analysers (Hemochron Jr and ACT Plus) in patients undergoing cardiac surgery using ANH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent cardiac surgery with heparin administration.\n\nExclusion Criteria:\n\n* Preoperative hemoglobin under 11g/dL\n* Weight under 40kg\n* Preoperative coagulopathy'}, 'identificationModule': {'nctId': 'NCT02484157', 'briefTitle': 'Comparison of ACT Between Hemochron Jr and ACT Plus', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Comparison of Activated Coagulation Time Between Hemochron Jr and ACT Plus During Cardiac Surgery for Patient Using Acute Normovolemic Hemodilution', 'orgStudyIdInfo': {'id': '2012-I0814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient', 'description': 'Patients were checked activated coagulation time by both Hemochron Jr and ACT Plus during cardiac surgery with heparin administration.', 'interventionNames': ['Device: Hemochron', 'Device: ACT Plus']}], 'interventions': [{'name': 'Hemochron', 'type': 'DEVICE', 'description': 'Activated coagulation time was checked serially by Hemochron Jr.', 'armGroupLabels': ['Patient']}, {'name': 'ACT Plus', 'type': 'DEVICE', 'description': 'Activated coagulation time was checked serially by ACT Plus.', 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KS009', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}], 'overallOfficials': [{'name': 'Soo Kyung Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hallym University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}