An observational study in COVID-19, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Indonesia University · Observational
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 100 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
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The study population was patients who had confirmed COVID-19 and underwent treatment at Cipto Mangunkusumo Hospital from October 2020 to March 2021. Subjects were eligible if they were adults (aged >18 years) who had positive SARS-CoV-2 nasopharyngeal swab examination with moderate to severe clinical symptoms.
Exclusion Criteria:
Have contraindications to the administration of anticoagulants, for example:
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 · Diagnostic Test: 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)
Diagnostic Test: Standard coagulation profile laboratory examination
Thromboelastography was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)
Also known as: TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)
Standard coagulation profile laboratory examination (platelets, PT/APTT, fibrinogen, and D-dimer) was performed by using Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan)
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Indonesia University