Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-30 @ 7:18 PM
Study NCT ID:
NCT05770232
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2023-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospectively Analyze the Risk Factors of VTE in 5774 Patients With Thoracic Trauma From 33 Hospitals in China, and Established a Risk Prediction Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D012253', 'term': 'Rib Fractures'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5774}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-04', 'studyFirstSubmitDate': '2023-03-04', 'studyFirstSubmitQcDate': '2023-03-04', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VTE', 'timeFrame': 'Peri-treatment period', 'description': 'venous thrombus embolism, including pulmonary embolism and deep vein thrombosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['venous thrombus embolism', 'Thorax Injuries', 'risk factors', 'prediction model'], 'conditions': ['Thorax Injuries', 'Embolism Vein', 'Embolism, Pulmonary', 'Rib Fractures']}, 'descriptionModule': {'briefSummary': 'Retrospectively analyze the risk factors of VTE in 5774 patients with thoracic trauma from 33 hospitals in China, and established a risk prediction model', 'detailedDescription': 'In order to explore the risk factors of VTE after acute thoracic trauma, we collected the diagnosis and treatment information of 5774 patients with thoracic trauma from 33 hospitals in China, retrospectively analyzed the risk factors of VTE in patients with thoracic trauma, and established a risk prediction model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18-80 years of age who were admitted within 3 days of chest trauma, did not have VTE prior to admission and were not receiving prophylactic anticoagulation. The chest trauma AIS score of QI patients with multiple injuries was greater than or equal to 3, and the chest trauma score of other combined injuries was less than or equal to 2.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted within three days of the chest trauma, VTE has not yet occurred, AIS score of thoracic injury was greater than or equal to 3, AIS score of other combined injuries was less than or equal to 2.\n\nExclusion Criteria:\n\n* received preventive physical or chemical anticoagulation before admission, VTE occurred before admission'}, 'identificationModule': {'nctId': 'NCT05770232', 'acronym': 'MCTTVTE', 'briefTitle': 'Retrospectively Analyze the Risk Factors of VTE in 5774 Patients With Thoracic Trauma From 33 Hospitals in China, and Established a Risk Prediction Model', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}, 'officialTitle': 'In Order to Explore the Risk Factors of VTE After Acute Thoracic Trauma, we Collected the Diagnosis and Treatment Information of 5774 Patients With Thoracic Trauma From 33 Hospitals in China, Retrospectively Analyzed the Risk Factors of VTE in Patients With Thoracic Trauma, and Established a Risk Prediction Model.', 'orgStudyIdInfo': {'id': 'multi-center thorax VTE'}}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Weigang Zhao', 'investigatorAffiliation': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}}}}