COVID-19NCT05343728
Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19 Patients
An observational study of COVID-19, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Thromboelastography and Standard coagulation profile laboratory examination
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2020to 9 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
- Pregnant
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: The Role of Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19
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.
Read the 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
- Being tested
- Thromboelastography, Standard coagulation profile laboratory examination
- Keywords
- Thromboelastography, Blood coagulation disorder, Mortality, intensive care unit
- Medical subject headings
- COVID-19, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDiagnostic test
Also called TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)
Thromboelastography was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)
Standard coagulation profile laboratory examinationDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Thromboelastography; Diagnostic Test: Standard coagulation profile laboratory examination | |
| 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) Receives: Diagnostic Test: Standard coagulation profile laboratory examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First day of admission in ICU/HCU
Secondary outcomes (3)
Result turnaround time
Calculation of the time (minutes) required from blood sample was taken until the examination result was done
Measured: 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
Measured: During hospitalization
Mortality
Death within 30 days after admission to the intensive care unit and/or high care unit
Measured: 30 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Oct 2020
- Primary completion1 Mar 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andi Ade Wijaya Ramlan, Universitas Indonesia
- Investigators
- Andi Ade Wijaya Ramlan, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343728
- Sponsor's protocol ID
- IndonesiaUAnes114
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19
- ClinicalTrials.gov ID
- NCT05343728
- Acronym / sponsor ID
- IndonesiaUAnes114
- Conditions
- COVID-19
- Keywords
- Thromboelastography, Blood coagulation disorder, Mortality, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thromboelastographic Methods | – | Diagnostic Test: Thromboelastography, Diagnostic Test: Standard coagulation profile laboratory examinationPatients whose coagulation profile were done by using a thromboelastography in addition to standard coagulation profile laboratory examination (thrombocyte count, PT, APTT, D-dimer, Fibrinogen) |
| Standard coagulation profile laboratory examination | – | Diagnostic Test: Standard coagulation profile laboratory examinationPatients whose coagulation profile were done by using a standard coagulation profile laboratory examination (thrombocyte count, PT, APTT, D-dimer, Fibrinogen) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- History of blood clotting disorders (eg, hemophilia and Von Willebrand's disease),
- Have contraindications to the administration of anticoagulants, for example:
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboelastographyAlso: TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)Thromboelastography was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA) | Diagnostic test | Thromboelastographic Methods |
| Standard coagulation profile laboratory examinationStandard coagulation profile laboratory examination (platelets, PT/APTT, fibrinogen, and D-dimer) was performed by using Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan) | Diagnostic test | Standard coagulation profile laboratory examination, Thromboelastographic Methods |
Primary outcome
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
3 secondary outcomes
Result turnaround time
Time frame: First day of admission in ICU/HCU
Length of stay in higher care
Time frame: During hospitalization
Mortality
Time frame: 30 days after hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andi Ade Wijaya Ramlan, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to anticoagulant therapy decision (time frame: First day of admission in ICU/HCU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.