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

NCT ID: NCT05343728

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-07-09

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Thromboelastographic Methods

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)

Thromboelastography

Intervention Type: DIAGNOSTIC_TEST

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

Standard coagulation profile laboratory examination

Intervention Type: DIAGNOSTIC_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)

Standard coagulation profile laboratory examination

Patients whose coagulation profile were done by using a standard coagulation profile laboratory examination (thrombocyte count, PT, APTT, D-dimer, Fibrinogen)

Standard coagulation profile laboratory examination

Intervention Type: DIAGNOSTIC_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)

Interventions

Thromboelastography

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

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Andi Ade Wijaya Ramlan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andi Ade Wijaya Ramlan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

IndonesiaUAnes114

Identifier Type: -

Identifier Source: org_study_id