Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 4:55 PM
Study NCT ID:
NCT05530161
Status:
UNKNOWN
Last Update Posted:
2022-09-07
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 371}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-06', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Internationalized Normalized Ratio (INR)', 'timeFrame': '24 hour', 'description': 'coagulation function :Internationalized Normalized Ratio (INR)'}, {'measure': 'Activated Partial Thromboplastin Time (APTT)', 'timeFrame': '24 hour', 'description': 'coagulation function : Activated Partial Thromboplastin Time (APTT)'}, {'measure': 'Prothrombin Time (PT)', 'timeFrame': '24 hour', 'description': 'coagulation function : Prothrombin Time (PT)'}], 'secondaryOutcomes': [{'measure': 'Blood products rate', 'timeFrame': 'through study completion, an average of 1 week', 'description': 'the rate of Blood products use'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trauma'], 'conditions': ['Coagulopathy', 'Trauma']}, 'descriptionModule': {'briefSummary': 'Hypocalcaemia is an independent risk factor of TIC in elderly trauma patients. TIC combined with hypocalcemia had worse coagulation function and more serious acidosis.', 'detailedDescription': 'This 5-year retrospective, observational, single-center study was conducted at the Second Affiliated Hospital of Zhejiang University Medical School (SAHZU, China). Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020.The purpose of this study is to elucidate the effect of hypocalcemia on TIC in elderly trauma patients through a single-center retrospective study, so as to further optimize the diagnosis and treatment strategies for TIC in elderly trauma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age≥65 years old\n* history of trauma\n\nExclusion Criteria:\n\n* previous anticoagulants or antiplatelet medication;\n* Coagulopathy caused by previous underlying diseases;\n* Blood products transfused before admission;\n* Cardiac arrest on admission;\n* Malignant tumor;\n* Data incomplete'}, 'identificationModule': {'nctId': 'NCT05530161', 'briefTitle': 'Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy', 'orgStudyIdInfo': {'id': '2020-822'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'trauma induced coagulopathy', 'description': 'patients with INR\\>1.2', 'interventionNames': ['Other: hypocalcemia']}, {'label': 'non-trauma induced coagulopathy', 'description': 'patients with INR≤1.2'}], 'interventions': [{'name': 'hypocalcemia', 'type': 'OTHER', 'description': 'hypocalcemia or normocalcemia', 'armGroupLabels': ['trauma induced coagulopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongan Xu', 'role': 'CONTACT', 'email': 'xuyongan2000@163.com', 'phone': '13757164833'}], 'facility': 'SAHZU'}], 'centralContacts': [{'name': 'yongan xu, doctor', 'role': 'CONTACT', 'email': 'xuyongan2000@163.com', 'phone': '13757164833'}, {'name': 'yangbo kang, master', 'role': 'CONTACT', 'email': '1179619719@qq.com', 'phone': '19858878803'}], 'overallOfficials': [{'name': 'yongan xu, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Emergency medicine，Second Affiliated Hospitalof Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}