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Clinical Trials/NCT05143567
NCT05143567
Completed
Not Applicable

Comprehensive Assessment of the Hemostasis and Inflammation in Patients With Venous and Arterial Thrombotic Complications in Treatment of New Coronaviral Infection (COVID-19)

Ryazan State Medical University1 site in 1 country150 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Thromboembolism
Sponsor
Ryazan State Medical University
Enrollment
150
Locations
1
Primary Endpoint
mortality
Status
Completed
Last Updated
2 years ago

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

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
July 23, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Agapov Andrey Borisovich

Post-doctoral researcher

Ryazan State Medical University

Eligibility Criteria

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.

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

Study Sites (1)

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