Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Baseline 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. We 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.

Official Title
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The Role of Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Thromboelastography
* Diagnostic Test: Standard coagulation profile laboratory examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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 Exclusion Criteria: History of blood clotting disorders (eg, hemophilia and Von Willebrand's disease), Have contraindications to the administration of anticoagulants, for example: Platelet count < 25,000 Has bleeding manifestations History of heparin allergy or heparin-induced thrombocytopenia Pregnant

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thromboelastographic Methods<br>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) | Diagnostic Test: Thromboelastography<br>* Thromboelastography was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)<br>* Other names: TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA);Diagnostic Test: Standard coagulation profile laboratory examination<br>* Standard coagulation profile laboratory examination (platelets, PT/APTT, fibrinogen, and D-dimer) was performed by using Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan)<br>|
| Standard coagulation profile laboratory examination<br>Patients whose coagulation profile were done by using a standard coagulation profile laboratory examination (thrombocyte count, PT, APTT, D-dimer, Fibrinogen) | Diagnostic Test: Standard coagulation profile laboratory examination<br>* Standard coagulation profile laboratory examination (platelets, PT/APTT, fibrinogen, and D-dimer) was performed by using Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to anticoagulant therapy decision | Calculation of the time (minutes) required from blood sample was taken until the decision on anticoagulant therapy made by the supervisors | First day of admission in ICU/HCU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result turnaround time | Calculation of the time (minutes) required from blood sample was taken until the examination result was done | First day of admission in ICU/HCU | 
| Length of stay in higher care | Length of stay in intensive care unit and/or high care unit during admission | During hospitalization | 
| Mortality | Death within 30 days after admission to the intensive care unit and/or high care unit | 30 days after hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboelastography, Blood coagulation disorder, Mortality, intensive care unit