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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343728
• Other study ID #: IndonesiaUAnes114
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: July 9, 2021

Study information

• Verified date: April 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 9, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Thromboelastography
Thromboelastography was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)
• Standard coagulation profile laboratory examination
Standard coagulation profile laboratory examination (platelets, PT/APTT, fibrinogen, and D-dimer) was performed by using Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan)

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of stay in higher care	Length of stay in intensive care unit and/or high care unit during admission	During hospitalization
Secondary	Mortality	Death within 30 days after admission to the intensive care unit and/or high care unit	30 days after hospital admission