The Role of Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Indonesia University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Time to anticoagulant therapy decision
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Andi Ade Wijaya Ramlan
Principal Investigator
Indonesia University
Eligibility Criteria
Inclusion Criteria
- •Confirmed COVID-19 (Positive SARS-CoV-2 PCR test),
- •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
- •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
Outcomes
Primary Outcomes
Time to anticoagulant therapy decision
Time Frame: First day of admission in ICU/HCU
Calculation of the time (minutes) required from blood sample was taken until the decision on anticoagulant therapy made by the supervisors
Secondary Outcomes
- Result turnaround time(First day of admission in ICU/HCU)
- Length of stay in higher care(During hospitalization)
- Mortality(30 days after hospital admission)