Covid-19 Associated Coagulopathy Predicted by Thrombodynamic Markers (CoViTro-I)
NCT ID: NCT05330832
Last Updated: 2022-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2200 participants
OBSERVATIONAL
2020-04-01
2022-04-21
Brief Summary
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Inclusion criteria are the following: patient informed concern, confirmed COVID-19 diagnosis, state of modern or critical condition.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with confirmed SARS-Cov-2 infection
Hospitalized patients with modern or critical condition with confirmed COVID-19 infection. Patients received standard therapy for COVID-19 infection and anticoagulant prophylaxis if needed according to current temporary clinical recommendations.
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.
Interventions
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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
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Inclusion Criteria
2. Confirmed COVID-19 diagnosis
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Federal Research Institute of Pediatric Hematology, Oncology and Immunology
OTHER
Responsible Party
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Locations
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Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow, , Russia
Countries
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Other Identifiers
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NCHPOI-2021-11
Identifier Type: -
Identifier Source: org_study_id
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