Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-29 @ 1:54 PM
Study NCT ID:
NCT05343728
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2022-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013916', 'term': 'Thrombelastography'}], 'ancestors': [{'id': 'D001780', 'term': 'Blood Coagulation Tests'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to anticoagulant therapy decision', 'timeFrame': 'First day of admission in ICU/HCU', 'description': 'Calculation of the time (minutes) required from blood sample was taken until the decision on anticoagulant therapy made by the supervisors'}], 'secondaryOutcomes': [{'measure': 'Result turnaround time', 'timeFrame': 'First day of admission in ICU/HCU', 'description': 'Calculation of the time (minutes) required from blood sample was taken until the examination result was done'}, {'measure': 'Length of stay in higher care', 'timeFrame': 'During hospitalization', 'description': 'Length of stay in intensive care unit and/or high care unit during admission'}, {'measure': 'Mortality', 'timeFrame': '30 days after hospital admission', 'description': 'Death within 30 days after admission to the intensive care unit and/or high care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thromboelastography', 'Blood coagulation disorder', 'Mortality', 'intensive care unit'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is a prospective observational study that compares the anticoagulant therapy decision time among moderate and severe COVID-19 patients whose coagulation profiles were tested with thromboelastography (TEG) to those with a standard coagulation profile laboratory examination.', 'detailedDescription': 'A prospective observational study was conducted among moderate to severe COVID-19 patients in the High Care Unit and Intensive Care Unit at Kiara Ultimate, Cipto Mangunkusumo Hospital, Indonesia. We consecutively recruited 100 moderate and severe COVID-19 patients in the high and intensive care units.\n\nBaseline characteristic data collection was carried out when the patient was admitted to the ICU or HCU. Venous blood was taken by nurses within 30 min of admission. The samples were sent to the centralized hospital laboratory for a standard hemostasis panel which consisted of platelets, PT/APTT, fibrinogen, and D-dimer. The hospital used Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan) for coagulation tests by using plasma derived from centrifuged whole blood samples. Bedside TEG examination was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA) with 2.5 ml of a whole blood sample. Samples of patients with heparin thromboprophylaxis were given heparinase, which binds to heparin so that the coagulation profile can be assessed. Except for TEG, all patients received equal diagnostic tests and treatment, including anticoagulant therapy, as indicated according to the national guideline. A trained doctor from the research team recorded time from blood samples taken until the coagulation panel or TEG results were obtained. Test result timestamp, anticoagulation decision timestamp, mortality, and length of stay in higher care were objectively retrieved through online medical records.\n\nWe compared the result turnaround time, time to decision of anticoagulant therapy, and clinical outcomes (length of stay and 30-day mortality) between those who had TEG examination in addition to standard coagulation profile examination (thrombocyte count, PT, APTT, D-dimer, and fibrinogen) and those who had a standard coagulation profile laboratory examination only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population was patients who had confirmed COVID-19 and underwent treatment at Cipto Mangunkusumo Hospital from October 2020 to March 2021. Subjects were eligible if they were adults (aged \\>18 years) who had positive SARS-CoV-2 nasopharyngeal swab examination with moderate to severe clinical symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Confirmed COVID-19 (Positive SARS-CoV-2 PCR test), 3. Moderate or severe symptoms (We defined moderate COVID-19 as patients with clinical signs of pneumonia with SpO2 \\>93% in room air and severe COVID-19 as pneumonia with SpO2 ≤93% in room air or ventilator support requirement), and 4. The family signed the informed consent\n\nExclusion Criteria:\n\n1. History of blood clotting disorders (eg, hemophilia and Von Willebrand's disease),\n2. Have contraindications to the administration of anticoagulants, for example:\n\n 1. Platelet count \\< 25,000\n 2. Has bleeding manifestations\n 3. History of heparin allergy or heparin-induced thrombocytopenia\n3. Pregnant"}, 'identificationModule': {'nctId': 'NCT05343728', 'briefTitle': 'Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Role of Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes114'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thromboelastographic Methods', 'description': 'Patients whose coagulation profile were done by using a thromboelastography in addition to standard coagulation profile laboratory examination (thrombocyte count, PT, APTT, D-dimer, Fibrinogen)', 'interventionNames': ['Diagnostic Test: Thromboelastography', 'Diagnostic Test: Standard coagulation profile laboratory examination']}, {'label': 'Standard coagulation profile laboratory examination', 'description': 'Patients whose coagulation profile were done by using a standard coagulation profile laboratory examination (thrombocyte count, PT, APTT, D-dimer, Fibrinogen)', 'interventionNames': ['Diagnostic Test: Standard coagulation profile laboratory examination']}], 'interventions': [{'name': 'Thromboelastography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)'], 'description': 'Thromboelastography was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)', 'armGroupLabels': ['Thromboelastographic Methods']}, {'name': 'Standard coagulation profile laboratory examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard coagulation profile laboratory examination (platelets, PT/APTT, fibrinogen, and D-dimer) was performed by using Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan)', 'armGroupLabels': ['Standard coagulation profile laboratory examination', 'Thromboelastographic Methods']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Cental National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Andi Ade Wijaya Ramlan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andi Ade Wijaya Ramlan', 'investigatorAffiliation': 'Indonesia University'}}}}