Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT01109667
Status:
COMPLETED
Last Update Posted:
2010-04-23
First Post:
2010-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Differences in Coagulation Test Kits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-22', 'studyFirstSubmitDate': '2010-04-22', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thromboplastin, Prothrombin, Diagnostic Reagent Kits, International Normalized Ratio, Laboratory Tests.'], 'conditions': ['Effect of Different Reagents.', 'Oral Anticoagulant Therapy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of Innovin® reagent on laboratory results when compared with the Thromborel® S.', 'detailedDescription': 'Thromboplastins are the screening tests which are used in the diagnosis of acquired or inherited disorders of the coagulation system but still, alterations between various thromboplastin preparations in the measurements remains a problem.Blood samples are going to drawn from patients receiving and not receiving oral anticoagulant therapy (OAT) during their routine laboratory tests. Samples are subjected to analysis by using Thromborel® S and Innovin® reagents. Mean International Normalized Ratio (INR), prothrombin time and fibrinogen values are going to compared. To further study the importance of this phenomenon the cohort will be divided into three subgroups according to the INR values as Group I: Patients not receiving OAT, Group II: Patients under OAT and INR values in good therapeutic range and Group III: Patients under OAT and INR values over the therapeutic range.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving and not receiving oral anticoagulant therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRoutine control patients receiving and not receiving oral anticoagulant therapy\n\nExclusion Criteria:\n\nHemolytic and/or lipemic samples were excluded.'}, 'identificationModule': {'nctId': 'NCT01109667', 'briefTitle': 'Differences in Coagulation Test Kits', 'organization': {'class': 'OTHER', 'fullName': 'Yuksek Ihtisas Hospital'}, 'officialTitle': 'The Effects of Different Reagents on Coagulation Tests: Innovin Versus Thromborel-S.', 'orgStudyIdInfo': {'id': 'EPK-235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'oral anticoagulant', 'description': 'Patients receiving and not receiving oral anticoagulant therapy.'}, {'label': 'INR Level', 'description': 'Group I: Patients not receiving OAT, Group II: Patients under OAT and INR values in good therapeutic range and Group III: Patients under OAT and INR values over the therapeutic range.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Turkiye Yuksek Ihtisas Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuksek Ihtisas Hospital', 'class': 'OTHER'}}}}