Back to resultsHemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications
Primary Purpose
Venous Thromboembolism, covid19, Thrombosis
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
standard of care anticoagulation in absence of thrombotic complications
standard of care anticoagulation in presence of thrombotic complications
standard of care anticoagulation in combination with elastic compression
Sponsored by
About this trial
This is an interventional other trial for Venous Thromboembolism focused on measuring venous thromboembolism, VTE, thrombotic events, coronavirus, COVID-19, hemostasis, platelet function
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.
Sites / Locations
- Ryazan State Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
patients with COVID-19 without thrombotic complications
patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE
patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE
Arm Description
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 with pharmacological 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.
Outcomes
Primary Outcome Measures
mortality
lethal outcomes
venous thrombosis or pulmonary embolism
a VTE event
arterial thrombosis
thrombosis of main arteries of the extremities or myocardial infarction or stroke
Secondary Outcome Measures
Full Information
NCT ID
NCT05143567
First Posted
November 20, 2021
Last Updated
February 2, 2022
Sponsor
Ryazan State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05143567
Brief Title
Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications
Official Title
Comprehensive Assessment of the Hemostasis and Inflammation in Patients With Venous and Arterial Thrombotic Complications in Treatment of New Coronaviral Infection (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ryazan State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, covid19, Thrombosis
Keywords
venous thromboembolism, VTE, thrombotic events, coronavirus, COVID-19, hemostasis, platelet function
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label cohort longitudinal study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with COVID-19 without thrombotic complications
Arm Type
Experimental
Arm Description
Group I: 50 patients with confirmed coronavirus infection without thrombotic complications
Arm Title
patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE
Arm Type
Experimental
Arm Description
Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE
Arm Title
patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
standard of care anticoagulation in absence of thrombotic complications
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
standard of care anticoagulation in presence of thrombotic complications
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
standard of care anticoagulation in combination with elastic compression
Intervention Description
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
Primary Outcome Measure Information:
Title
mortality
Description
lethal outcomes
Time Frame
one year
Title
venous thrombosis or pulmonary embolism
Description
a VTE event
Time Frame
one year
Title
arterial thrombosis
Description
thrombosis of main arteries of the extremities or myocardial infarction or stroke
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Suchkov, MD, PhD
Phone
+7(4912) 97-18-01
Email
suchkov_med@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Suchkov, MD, PhD
Organizational Affiliation
Ryazan State Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Ryazan State Medical University
City
Ryazan'
ZIP/Postal Code
390026
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey Agapov, MD, PhD
Phone
+7(4912) 97-18-01
Email
agapchik2008@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications
We'll reach out to this number within 24 hrs