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

Indonesia University100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

COVID-19

Interventions

ThromboelastographyDIAGNOSTIC_TEST

Thromboelastography was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)

Standard coagulation profile laboratory examinationDIAGNOSTIC_TEST

Standard coagulation profile laboratory examination (platelets, PT/APTT, fibrinogen, and D-dimer) was performed by using Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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: 1. History of blood clotting disorders (eg, hemophilia and Von Willebrand's disease), 2. Have contraindications to the administration of anticoagulants, for example: 1. Platelet count \< 25,000 2. Has bleeding manifestations 3. History of heparin allergy or heparin-induced thrombocytopenia 3. Pregnant

Locations (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

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

Time frame: First day of admission in ICU/HCU

Secondary Outcomes

Result turnaround time

Calculation of the time (minutes) required from blood sample was taken until the examination result was done

Time frame: 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

Time frame: During hospitalization

Mortality

Death within 30 days after admission to the intensive care unit and/or high care unit

Time frame: 30 days after hospital admission

Data from ClinicalTrials.gov

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