Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications

Ryazan State Medical University

Status: Completed

Conditions: covid19; Venous Thromboembolism; Thrombosis

Treatments: Other: standard of care anticoagulation in combination with elastic compression; Other: standard of care anticoagulation in presence of thrombotic complications; Other: standard of care anticoagulation in absence of thrombotic complications

Study type: Interventional

Funder types: Other

Identifiers

NCT05143567

11.10.2021

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• men or women over 18 years of age with a new coronavirus infection, confirmed by polymerase chain reaction (PCR) studies and chest CT.

Exclusion criteria

• men or women under 18 years of age; active cancer or a remission period of less than 5 years; decompensated somatic pathology; pregnancy or breastfeeding in women.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

patients with COVID-19 without thrombotic complications

Experimental group

Description:

Group I: 50 patients with confirmed coronavirus infection without thrombotic complications

Treatment:

Other: standard of care anticoagulation in absence of thrombotic complications

patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE

Experimental group

Description:

Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE

Treatment:

Other: standard of care anticoagulation in presence of thrombotic complications

patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE

Experimental group

Description:

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.

Treatment:

Other: standard of care anticoagulation in combination with elastic compression