Thrombohemorrhagic Complications of COVID-19

NCT06223945 | Active Not Recruiting

• 1 other identifier: 12/2024/01/12
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The nature of the planned study: The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes. It is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with COVID-19 during the pandemic (8 cities). As a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with COVID-19. The proposed study will be multicenter, cohort, retrospective. The purpose of the study: Improvement of treatment results in COVID-19 patients with thrombotic or hemorrhagic complications Scientific novelty: For the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with COVID-19. For the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of COVID-19.

Conditions

COVID-19 (Coronavirus Disease 2019)

Outcome Measures

Primary Outcomes (1)

• development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19

  It is planned to perform a multicenter cohort retrospective study with an expanded analysis of the clinical features of the course, the results of surgical treatment, intensive care, anesthesiological and resuscitation benefits in patients with COVID-19, the course of which was complicated by thrombotic and hemorrhagic complications, including internal and external bleeding from the hollow organs of the abdominal cavity, retroperitoneal space and chest. The material for the study will be formed by combining data from several large clinics, on the basis of which infectious diseases hospitals with a concentration of surgical patients have been deployed. Based on the cumulative assessment of the results obtained, new and improved previously developed surgical and anesthetic-resuscitation algorithms for diagnosis, surgical tactics, intensive care in patients with COVID-19 with thrombotic and hemorrhagic complications in need of surgical and resuscitation procedures will be proposed.

  5 years

Study Arms (2)

Thrombotic and hemorrhagic complications of COVID-19

ACTIVE COMPARATOR

Diagnostic Test: Prevention algorithm

Prevention of thrombohemorrhagic complications in COVID-19

ACTIVE COMPARATOR

Diagnostic Test: Prevention algorithm

Interventions

Prevention algorithm DIAGNOSTIC_TEST

Development of an algorithm for the prevention of thrombohemorrhagic complications

Prevention of thrombohemorrhagic complications in COVID-19; Thrombotic and hemorrhagic complications of COVID-19

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with thrombohemorrhagic complications who were treated in a covid hospital

You may not qualify if:

• Cancer patients
• Patients who had thrombohemorrhagic disorders before admission to the hospital
• Pregnant women
• Patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital

Sponsors & Collaborators

• Volgograd State Medical University: lead

Study Sites (1)

Clinic №1 of Volgograd State Medical University

Volgograd, 400079, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Viktor Mikhin

  Volgograd State Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 25, 2024
• Study Start: January 12, 2024
• Primary Completion (Estimated): January 12, 2029
• Study Completion (Estimated): January 12, 2029
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

RU (1)