Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05343728 |
Other study ID # |
IndonesiaUAnes114 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.