Official Title
Covid-19 Associated Coagulopathy Predicted by Thrombodynamic Markers (CoViTro-I)
Brief Summary

The aim of the study is estimating the predictive and preventative capability ofthrombodynamics for severe pneumonia coagulopathy complications in patients with COVID-19infection. Thrombodynamics test is a method for blood coagulation and anticoagulationmonitoring. It could be a useful tool for predicting thrombohemorrhagic complications inpatients with COVID-19 infection and developing a novel scheme of anticoagulant therapy.Inclusion criteria are the following: patient informed concern, confirmed COVID-19diagnosis, state of modern or critical condition.

Detailed Description

The novel coronavirus viral infection (currently classified as COVID-19) causes a
significant increase in death rate worldwide. Most of the patients with COVID-19 develop
respiratory failure as well as coagulopathy.

The International Society of Thrombosis and Hemostasis (ISTH) has recently published
guidelines for the treatment of coagulopathies in patients with COVID-19. It suggests
using prophylactic doses of low molecular weight heparin (LMWH) in all patients with
COVID-19. Numerous studies show a high percentage of thromboembolic complications in
patients with COVID-19 as well as its potential association with pulmonary vessels
microthrombosis and the development of acute respiratory distress syndrome. It is
believed that COVID-19-associated coagulopathy could happen presumably due to the
systemic inflammation. However, there are still no unified criteria for anticoagulant
prophylaxis in such patients.

What is more, the severity of COVID-19 infection is also associated with high risk of
life-threatening conditions such as sepsis and disseminated intravascular coagulation
syndrome with massive uncontrolled bleeding.

According to the current clinical guidelines, coagulopathy in COVID-19 can be only
registered with standard tests (prothrombin time (PT), platelet concentration and
D-dimer). However, the lengthening of PT and the drop in platelet concentration are
useful for the indication of the consumption stage of DIC. These changes mean that any
patient remains already at risk of bleeding and the LMWH is no longer effective. The
concentration of D-dimers shows the lysis of clots formed as a result of
hypercoagulation, which also makes it a "delayed" marker of hypercoagulation. Thus, there
are currently no reliable laboratory tools for hypercoagulation diagnostics in patients
with COVID-19.

Thrombodynamics test is a global hemostasis test that allows to register the dynamics of
fibrin clot formation in time and space. This test is highly sensitive to both hyper- and
hypocoagulation and, at the same time, it allows to control anticoagulant therapy with
heparins. The use of thrombodynamics test for the prediction of thrombohemorrhagic
complications in this group of patients could be useful for individual correction of
anticoagulant treatment and prevention of coagulopathy in COVID-19.

The aim of the study is estimating the predictive capability of thrombodynamics for
SARS-CoV-2 associated coagulopathy in patients with severe pneumonia.

Unknown status
Coronavirus Disease 2019

Diagnostic Test: Thrombodynamics test

Thrombodynamics test is a global hemostasis test that allows to register the dynamics of
fibrin clot formation in time and space. It requires whole blood samples from included
patients.

Eligibility Criteria

Inclusion Criteria:

1. Patient (or the health care surrogate) Informed consent

2. Confirmed COVID-19 diagnosis

Exclusion Criteria:

1) Patient (or the health care surrogate) refusal to participate in this study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Russian Federation
Locations

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow, Russian Federation

Not Provided

Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT Number
Keywords
Covid-19
Venous Thromboembolism
Pulmonary Embolism
Myocardial infarction
Ischemic Stroke
atherothrombosis
MeSH Terms
COVID-19