Thrombohemorrhagic Complications of COVID-19

January 24, 2024 updated by: Volgograd State Medical University

Surgical and Anesthesiological-resuscitation Aspects of Therapeutic Tactics for Thrombotic and Hemorrhagic Complications in Patients With the New Coronavirus Infection COVID-19

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Volgograd, Russian Federation, 400079
        • Clinic №1 of Volgograd State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thrombotic and hemorrhagic complications of COVID-19
Diagnostic test: Prevention algorithm
Development of an algorithm for the prevention of thrombohemorrhagic complications
Active Comparator: Prevention of thrombohemorrhagic complications in COVID-19
Diagnostic test: Prevention algorithm
Development of an algorithm for the prevention of thrombohemorrhagic complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volgograd State Medical University

Investigators

  • Study Chair: Viktor Mikhin, Volgograd State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

January 12, 2029

Study Completion (Estimated)

January 12, 2029

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/2024/01/12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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