Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT06269302
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effect of Warfarin and Direct Oral Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'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'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the incidence of recurrent bleeding', 'timeFrame': '12 months', 'description': 'Increase or decrease in the incidence of recurrent bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal System', 'Oral Anticoagulant', 'Rebleeding', 'upper gastrointestinal system bleeding'], 'conditions': ['Anticoagulants and Bleeding Disorders', 'Gastrointestinal Hemorrhage']}, 'descriptionModule': {'briefSummary': 'In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding', 'detailedDescription': "The data of all patients who applied to Samsun Training and Research Hospital Internal Medicine with a diagnosis of upper gastrointestinal bleeding and hospitalized by Internal Medicine and Gastroenterology clinics or who underwent outpatient endoscopy between 01.01.2021 and 31.12.2021 were included. The patients' data were analyzed from the patient files and hospital automation system retrospectively. Patients who had recurrent upper GI bleeding were detected by controlling them over the hospital software system and by reaching each patient again. The frequency of the new generation oral anticoagulants usage in patients with re-bleeding was determined, and data such as re-bleeding rate, length of hospital stay, need for transfusion, and mortality were analyzed in the groups who did not use this drug and those who used it. The patient demographics were also compared between the groups who were using the new generation oral anticoagulants, acetylsalicylic acid or warfarin."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who were admitted to Samsun Training and Research Hospital with a diagnosis of upper gastrointestinal bleeding and hospitalized by Internal Medicine and Gastroenterology clinics or who underwent outpatient endoscopy were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years old\n* Upper gastrointestinal bleeding\n* 12 months follow-up\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Lower gastrointestinal bleeding\n* Esophageal variceal bleeding'}, 'identificationModule': {'nctId': 'NCT06269302', 'briefTitle': 'Comparison of the Effect of Warfarin and Direct Oral Anticoagulants', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Education and Research Hospital'}, 'officialTitle': 'Comparison of the Effect of Warfarin and Direct Oral Anticoagulants on Upper Gastrointestinal System Bleeding', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with recurrent gastrointestinal bleeding', 'description': 'The data of all patients who applied to Samsun Training and Research Hospital for 12 months in 2022 and diagnosis of upper gastrointestinal bleeding and hospitalized by Internal Medicine and Gastroenterology clinics or who underwent outpatient endoscopy were included in the study.Patients who had recurrent upper GI bleeding were detected by controlling them over the hospital software system and by reaching each patient again. The frequency of use of new generation oral anticoagulants in patients with rebleeding was determined, and data such as rebleeding rate, length of hospital stay, need for transfusion, and mortality were analyzed in the groups who did not use this drug and those who used it.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Samsun', 'state': 'İlkadım', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun Education and Research Hospital', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'DÜRİYE SILA KARAGÖZ ÖZEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsun Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Internal Medicine Specialist', 'investigatorFullName': 'Duriye Sila Karagoz Ozen', 'investigatorAffiliation': 'Samsun Education and Research Hospital'}}}}