Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-30 @ 5:12 PM
Study NCT ID:
NCT05995093
Status:
UNKNOWN
Last Update Posted:
2023-10-24
First Post:
2023-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004211', 'term': 'Disseminated Intravascular Coagulation'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 462}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-12', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'whether DIC occured', 'timeFrame': 'From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.', 'description': 'DIC includes pre-DIC and overt-DIC'}], 'secondaryOutcomes': [{'measure': 'whether death occurred', 'timeFrame': 'From date of admission until the date of death, assessed up to 5 months', 'description': 'Based on the death records in the electronic medical records'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombosis', 'Coagulation', 'Hemostatic Biomarkers', 'DIC'], 'conditions': ['Disseminated Intravascular Coagulation']}, 'descriptionModule': {'briefSummary': 'The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.', 'detailedDescription': 'Disseminated intravascular coagulation (DIC) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. However, current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing for proactive diagnosis before the disease progresses into its irreversible phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '94 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults patients admitted to intensive care unit of Qilu Hospital from 1 January 2021 to 31 December 2022 were involved in our study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old, non-perinatal period, a hospitalization length of≥3 days.\n\nExclusion Criteria:\n\n* primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.'}, 'identificationModule': {'nctId': 'NCT05995093', 'briefTitle': 'The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation', 'orgStudyIdInfo': {'id': 'Hemostatic Biomarkers in DIC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-DIC group', 'interventionNames': ['Other: no intervention']}, {'label': 'pre-DIC group', 'interventionNames': ['Other: no intervention']}, {'label': 'overt-DIC group', 'interventionNames': ['Other: no intervention']}, {'label': 'DIC group', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['DIC group', 'non-DIC group', 'overt-DIC group', 'pre-DIC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': "Ji'nan", 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Miao Xu, MD, PhD', 'role': 'CONTACT', 'email': 'miao.xu@sdu.edu.cn', 'phone': '0531-82169885'}], 'facility': 'Miao Xu'}], 'centralContacts': [{'name': 'Miao Xu', 'role': 'CONTACT', 'email': 'miao.xu@sdu.edu.cn', 'phone': '0531-82169885'}], 'overallOfficials': [{'name': 'Miao Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Miao Xu, MD', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}