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The study is aimed at assessing the role of the activity of high-risk markers of thrombotic events (MCP-1, MIP1α, IP-10, phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.
The study is aimed at assessing the role of the activity of high-risk markers for thrombotic events (monocytic chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP1α), interferon-induced gamma protein-10 (IP-10), platelet apoptosis markers (phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.
The study will include 150 patients of similar age, gender, and ethnicity, and they will be divided into three groups: Group I: 50 patients with confirmed coronavirus infection without thrombotic complications; Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography without the use of pharmacomechanical prophylaxis of VTE; Group III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with COVID-19 without thrombotic complications | Experimental | Group I: 50 patients with confirmed coronavirus infection without thrombotic complications |
|
| patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE | Experimental | Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE |
|
| patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE | Experimental | Group III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care anticoagulation in absence of thrombotic complications | Other | Subgroup IA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IB - patients receive LMWH (enoxaparin) for the prevention or treatment of VTE Subgroup IC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | lethal outcomes | one year |
| venous thrombosis or pulmonary embolism | a VTE event | one year |
| arterial thrombosis | thrombosis of main arteries of the extremities or myocardial infarction or stroke | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor Suchkov, MD, PhD | Ryazan State Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryazan State Medical University | Ryazan | 390026 | Russia |
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Open-label cohort longitudinal study
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| standard of care anticoagulation in presence of thrombotic complications | Other | Subgroup IIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) for the prevention or treatment of VTE Subgroup IIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE |
|
| standard of care anticoagulation in combination with elastic compression | Other | Subgroup IIIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE |
|
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D000086382 | COVID-19 |
| D013927 | Thrombosis |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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