Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-26 @ 5:59 PM
Study NCT ID:
NCT05487066
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of ICU-VTE Scale in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of VTE', 'timeFrame': '28-day', 'description': 'inhospital venous thromboembolism occurrence'}], 'secondaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '28-day', 'description': 'Death from all causes during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous thromboembolism', 'Deep vein thrombosis', 'ICU', 'Critically ill'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'Venous thromboembolism (VTE) is a common cause of morbidity and mortality among critically ill patients. No uniform standard model of VTE risk for critically ill patients was formatted by now. In 2020, Viarasilpa et al. developed the ICU⁃VTE rating table, mainly for ICU patients. However, it lacks validation. We examined and compared how well the ICU-VTE score predict and stratify VTE risk in comprehensive ICU patients.', 'detailedDescription': 'Venous thromboembolism (VTE) is a group of thromboembolic diseases including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), which is a systemic disease caused by a combination of risk factors. The risk of venous thromboembolism can be greatly reduced by the preventive treatment of it in hospitalized patients according to their risk level. The common risk assessment tools for inpatient VTE include the Padua score for medical patients and the Caprini score for surgical patients, but there is no clinical basis for implementing risk assessment for critically ill patients. The question of how to perform VTE risk assessment in ICU patients to prevent and treat the occurrence of VTE is worth exploring.\n\nThis study was designed according to a prospective study method. Data and information were collected from the time the patients were admitted to the ICU to the time the patients were discharged from the ICU.There are three purposes for this study. First, to observe the predictive effect and evaluate the value of the ICU-VTE scoring scale in comprehensive ICU patients; Second, to compare the advantages and disadvantages of the ICU-VTE scoring tool with the Padua score (internal medicine) and Caprini score tool (surgery); To analyze the risk factors for VTE in comprehensive ICU patients and to optimize the VTE risk prediction model; Third, to look into the prevention and treatment of VTE in critically ill ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatient in intensive care unit department of Wuhan Central Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients age greater than or equal to 18 years;\n* Patients or their family members agreed to the study and signed informed consent.\n\nExclusion Criteria:\n\n* Patients admitted to ICU with VTE diagnosis or diagnosed with VTE within 24 hours of admission to ICU;\n* Use the therapeutic dose of anticoagulation before admission to ICU or within 24 hours in ICU;\n* Expected ICU stay of less than 48 hours;\n* Patients cannot obtain imaging data to confirm the presence of VTE during ICU admission'}, 'identificationModule': {'nctId': 'NCT05487066', 'briefTitle': 'Efficacy of ICU-VTE Scale in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Central Hospital'}, 'officialTitle': 'Efficacy of ICU-VTE Scale in Predicting Venous Thromboembolism in ICU Patients', 'orgStudyIdInfo': {'id': 'WHZXKYL2022-117'}}, 'contactsLocationsModule': {'locations': [{'zip': '430014', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'The Central Hospital of Wuhan', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Juan Li Zhang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intensive Care Unit, the Central Hospital of Wuhan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lijuan Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'physician', 'investigatorFullName': 'Lijuan Zhang', 'investigatorAffiliation': 'Wuhan Central Hospital'}}}}