Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 7:28 AM
Study NCT ID:
NCT05998733
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2023-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 552}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The plasma concentration of fibrin degradation products(FDP) in ug/ml', 'timeFrame': 'within 3 days of admission before the use of anticoagulant drugs', 'description': 'The plasma concentration of fibrin degradation products(FDP) was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs'}, {'measure': 'The plasma concentration of DDimer in ug/ml', 'timeFrame': 'within 3 days of admission before the use of anticoagulant drugs', 'description': 'The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'coagulation disorders'], 'conditions': ['Sepsis', 'Coagulation Disorder']}, 'descriptionModule': {'briefSummary': 'The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who also met the criteria of the presence of clinical infections and Sequential Organ Failure Assessment (SOFA) score ≥2; and 3) met the exclusion criteria, and retrospectively collected coagulation indices of the patients before anticoagulation with or without the use of heparin or low molecular heparin, and recorded the worst values of coagulation function of patients before heparin were recorded, and the organ function, inflammatory response, immune indexes, and conversion rate of severe disease were observed, so as to investigate the role of conventional coagulation indexes (FDP, D-dimer) and thromboelastography in the early diagnosis of septicemia patients and to indicate the prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period 2013.1.1-2019.12.31, all patients who met the enrollment criteria were screened, and the coagulation function indexes of patients with or without heparin or low molecular heparin before anticoagulation were retrospectively collected, the worst value of coagulation function of patients before heparin was recorded, and the organ function, inflammatory response, immune indexes, and the rate of conversion to severe disease of the patients were observed, so as to To investigate the role of conventional coagulation indices (FDP, D-dimer) and thromboelastography in the early diagnosis and prognosis of patients with sepsis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Time from clinical symptoms to admission ≤ 7 days；\n* infection was diagnosed by clinician\n* Systemic inflammatory response syndrome，Systemic inflammatory response syndrome was defined as the presence of 2 or more of the following: (1) temperature \\<36℃or \\>38℃, (2) heart rate \\>90 beats per minute, (3) respiratory rate \\>20 breaths per minute or PaCO2 \\< 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm\n\nExclusion Criteria:\n\n* Pregnancy and lactation\n* Have hematological diseases (including acute and chronic leukemia, hemolytic anemia, hemophilia, aplastic anemia, bone marrow fibrosis, congenital or acquired coagulation factor deficiency, etc.)\n* Anticoagulant or antiplatelet drug treatment\n* 24 hours after severe trauma or surgery\n* Autoimmune diseases\n* cirrhosis\n* Malignant tumor patients with personal history or undergoing radiotherapy, chemotherapy and targeted treatment'}, 'identificationModule': {'nctId': 'NCT05998733', 'briefTitle': 'The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study', 'orgStudyIdInfo': {'id': '202300123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sepsis group', 'description': 'diagnostic sepsis；age\\>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection② Sequential Organ Failure Assessment (SOFA) score ≥ 2 points at admission', 'interventionNames': ['Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring']}, {'label': 'non-sepsis group', 'description': 'diagnostic sepsis；age\\>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection②Systemic inflammatory response syndrome(SIRS)，SIRS was defined as the presence of 2 or more of the following: (1) temperature \\<36℃or \\>38℃, (2) heart rate \\>90 beats per minute, (3) respiratory rate \\>20 breaths per minute or PaCO2 \\< 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm', 'interventionNames': ['Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring']}], 'interventions': [{'name': 'Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': '* Correlation analysis of sepsis severity with FDP and D-Dimer\n* Discussion on the critical value and area under the curve of FDP and D-Dimer in diagnosis of sepsis\n* Differences in age and sex of FDP and D-Dimer in diagnosis of sepsis\n* Effect of FDP and D-Dimer diagnosis of sepsis on severe conversion rate and all-cause mortality of patients\n* The difference of thromboelastogram in patients with sepsis of different severity\n* Thromboelastogram items (R time α Correlation between angle, k time, maximum blood clot strength and comprehensive coagulation index) and sepsis', 'armGroupLabels': ['non-sepsis group', 'sepsis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peili Chen, MD', 'role': 'CONTACT', 'email': 'elodiechen1986@163.com', 'phone': '+86 18502185109'}, {'name': 'Enqiang Mao, PhD', 'role': 'CONTACT', 'email': 'maoeq@yeah.net', 'phone': '+86 13501747906'}], 'facility': 'Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'peili CHEN, MD', 'role': 'CONTACT', 'email': 'elodiechen1986@163.com', 'phone': '+86 18502185109'}, {'name': 'Enqiang MAO, PhD', 'role': 'CONTACT', 'email': 'maoeq@yeah.net', 'phone': '+86 13501747906'}], 'overallOfficials': [{'name': 'Enqiang Mao, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}