Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-04-30 @ 9:17 PM
Study NCT ID:
NCT01521858
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2012-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THRA_hematologic Variables
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative bleeding volume', 'timeFrame': 'at first postoperative day'}, {'measure': 'Hemoglobin', 'timeFrame': 'preoperative 1 day and postoperative 1 day'}, {'measure': 'hematocrit', 'timeFrame': 'preoperative 1 day and postoperative 1 day'}, {'measure': 'platelet', 'timeFrame': 'preoperative 1 day and postoperative 1 day'}, {'measure': 'prothrombin time_international normalized ratio', 'timeFrame': 'preoperative 1 day and postoperative 1 day'}, {'measure': 'activated partial prothrombin time', 'timeFrame': 'preoperative 1 day and postoperative 1 day'}, {'measure': 'fibrinogen concentration', 'timeFrame': 'preoperative 1 day and postoperative 1 day'}, {'measure': 'Rotational thromboelastometry', 'timeFrame': 'preoperative 1 day and postoperative 1 day'}], 'secondaryOutcomes': [{'measure': 'volume of infused fluid during operation', 'timeFrame': 'Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)', 'description': 'Infused total crystalloid and colloid volume during the operation will be recorded.'}, {'measure': 'intraoperative urine output', 'timeFrame': 'Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)'}, {'measure': 'transfusion units', 'timeFrame': 'Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day', 'description': 'Red blood cell'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Avascular Necrosis of Hip']}, 'descriptionModule': {'briefSummary': 'Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients diagosed with avascular necrosis of hip and undergoing total hip replacement arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* avascular necrosis of hip\n* total hip replacement arthroplasty\n\nExclusion Criteria:\n\n* revision operation\n* hematologic disease\n* anticoagulant medication\n* preoperative hemoglobin \\< 10 g/dl\n* preoperative transfusion of red blood cells'}, 'identificationModule': {'nctId': 'NCT01521858', 'briefTitle': 'THRA_hematologic Variables', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Relations Between Hematologic Variables and Postoperative Bleeding in Total Hip Replacement Arthroplasty', 'orgStudyIdInfo': {'id': 'B_1111_140_103'}}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam', 'state': 'Gyounggi', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}