Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-27 @ 2:02 AM
Study NCT ID:
NCT06539156
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2024-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prescribing Appropriateness of Thrombo-prophylaxis in Intensive Care Unit of Tertiary Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Padua score for medical patients', 'timeFrame': 'within 24 hours of ICU admission', 'description': 'Venous thromboembolism Risk assessment (Scores 0-3 are low risk and do not warrant prophylaxis. Scores ≥4 are high risk for VTE and subsequent complications; recommendation for thromboprophylaxis.)'}, {'measure': 'Caprini score for surgical patients', 'timeFrame': 'within 24 hours of ICU admission', 'description': 'Venous thromboembolism Risk assessment (Total score of 0-1: Low risk of VTE Total score of ≥3: High/moderate risk of VTE )'}], 'secondaryOutcomes': [{'measure': 'Bleeding risk assessment', 'timeFrame': 'within 24 hours of ICU admission'}, {'measure': 'Direct Anticoagulant cost', 'timeFrame': 'within 24 hours of ICU admission till ICU discharge(at least 48 hours)', 'description': 'sum of costs related to the anticoagulant administration for DVT Prophylaxis'}, {'measure': 'Adverse drug reaction cost', 'timeFrame': 'within 24 hours of ICU admission till ICU discharge (at least 48 hours)', 'description': 'sum of costs related to the Adverse drug reaction for DVT Prophylaxis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['DVT']}, 'descriptionModule': {'briefSummary': "Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. Methods A cross-sectional single-center study will be conducted between July 2024 and December 2024, including hospitalized (\\> 48 h), (≥ 60 years), medical and surgical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua and caprine prediction scores will be used to determine the patients' risk for VTE, and thromboprophylaxis use will be assessed against the ACCP recommendations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient records admitted to the ICU with medical or surgical causes treated with anticoagulants for DVT prophylaxis will be collected Patients already on anticoagulant therapy, had history of previous DVT, had End-stage liver disease, admitted with hemorrhage/bleeding or not prescribed DVT prophylaxis will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient records\n\n* admitted to the ICU with\n* medical or surgical causes\n* recieved anticoagulants for DVT prophylaxis\n\nExclusion Criteria:\n\n* Patients already on anticoagulant therapy,\n* had history of previous DVT,\n* had End-stage liver disease,\n* admitted with hemorrhage/bleeding\n* not prescribed DVT prophylaxis'}, 'identificationModule': {'nctId': 'NCT06539156', 'briefTitle': 'Prescribing Appropriateness of Thrombo-prophylaxis in Intensive Care Unit of Tertiary Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Pattern of Prescribing Anticoagulants As DVT Prophylaxis in Intensive Care Unit of Tertiary Hospital', 'orgStudyIdInfo': {'id': '2887764466'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical Patients', 'interventionNames': ['Other: DVT prophyllaxis']}, {'label': 'Surgical Patients', 'interventionNames': ['Other: DVT prophyllaxis']}], 'interventions': [{'name': 'DVT prophyllaxis', 'type': 'OTHER', 'description': 'VTE prophylaxis administration among patients based on the American College of Chest Physicians (ACCP) recommendations', 'armGroupLabels': ['Medical Patients', 'Surgical Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4270020', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Teachers Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Egyptian Chinese University', 'class': 'OTHER'}, {'name': 'Teachers Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacy Associate Professor', 'investigatorFullName': 'Sarah Sabry Hashem', 'investigatorAffiliation': 'Egyptian Chinese University'}}}}