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

Not Applicable

Completed

• Conditions: Venous Thromboembolism; covid19; Thrombosis

• Registration Number: NCT05143567
• Lead Sponsor: Ryazan State Medical University

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-20
• Study First Submitted QC: 2021-11-20
• Study First Posted: 2021-12-03
• Primary Completion: 2023-07-23
• Study Completion: 2023-07-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mortality	one year	lethal outcomes
venous thrombosis or pulmonary embolism	one year	a VTE event
arterial thrombosis	one year	thrombosis of main arteries of the extremities or myocardial infarction or stroke

Trial Locations

Locations (1)

Ryazan State Medical University; 🇷🇺 Ryazan', Russian Federation