NCT05343728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 21, 2022

Last Update Submit

April 21, 2022

Conditions

COVID-19

Keywords

ThromboelastographyBlood coagulation disorderMortalityintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Result turnaround time

    First day of admission in ICU/HCU

  • Length of stay in higher care

    During hospitalization

  • Mortality

    30 days after hospital admission

Study Arms (2)

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)

Diagnostic Test: ThromboelastographyDiagnostic 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)

Diagnostic Test: Standard coagulation profile laboratory examination

Interventions

ThromboelastographyDIAGNOSTIC_TEST

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

Also known as: TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA)
Thromboelastographic Methods
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)

Standard coagulation profile laboratory examinationThromboelastographic Methods

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \. 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

COVID-19Blood Coagulation Disorders

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Andi Ade Wijaya Ramlan, MD, PhD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 25, 2022

Study Start

October 1, 2020

Primary Completion

March 1, 2021

Study Completion

July 9, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

ID(1)