Comprehensive Assessment of the Hemostasis and Inflammation in Patients With Venous and Arterial Thrombotic Complications in Treatment of New Coronaviral Infection (COVID-19)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- mortality
Study Overview
Brief Summary
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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
patients with COVID-19 without thrombotic complications
Group I: 50 patients with confirmed coronavirus infection without thrombotic complications
Intervention: standard of care anticoagulation in absence of thrombotic complications (Other)
patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE
Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE
Intervention: standard of care anticoagulation in presence of thrombotic complications (Other)
patients with COVID-19 and VTE who received 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.
Intervention: standard of care anticoagulation in combination with elastic compression (Other)
Outcomes
Primary Outcomes
mortality
Time Frame: one year
lethal outcomes
venous thrombosis or pulmonary embolism
Time Frame: one year
a VTE event
arterial thrombosis
Time Frame: one year
thrombosis of main arteries of the extremities or myocardial infarction or stroke
Secondary Outcomes
No secondary outcomes reported
Investigators
Agapov Andrey Borisovich
Post-doctoral researcher
Ryazan State Medical University