Thromboembolic Complications in COVID-19 Patients in Intensive Care Unit (COVID-19TC)

January 24, 2024 updated by: Ayse Zeynep Turan

Incidence of Thromboembolism in COVID-19 Infection in the ICU: a Retrospective Cohort Analysis

The present study aims to determine frequency of thromboembolic complications and the underlying causes of this complication of the patients who admitted to the intensive care unit diagnosed with COVID-19.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients diagnosed with COVID-19 infection and admitted to the ICU were recruited. Demographic information, comorbidities, length of ICU stay, some laboratory data,thromboembolic complications of the patients were recorded.

Study Type

Observational

Enrollment (Actual)

484

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

  • Turkey
    • Derince
      • Kocaeli, Derince, Turkey, 41900
        • Derince Research and Training Hospital

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

Sampling Method

Probability Sample

Study Population

Study Population of the present study is all of the patients diagnosed with COVID-19 and admitted to the intensive care units at Derince Training and Research Hospital at the time of between 1-March-2020 and 31-December-2021in

Description

Inclusion Criteria:

  • Patients who were infected with COVID-19 and admitted to the intensive care unit between the time of March 2020-December 2021

Exclusion Criteria:

  • who is under 18 years old.

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

Cohorts and Interventions

Group / Cohort
Ancestral variant
Ancestral variant is the first subtype of SARS CoV-2 virus which is the agent of first COVID-19 infection in Wuhan. Thromboembolic complications of this group were detected among patients which were infected with ancestral variant of COVID-19
Delta Variant
Delta variant is the subtype of SARS CoV-2 virus which is first COVID-19 subtype identified in India. Thromboembolic complications of this group were detected among patients which were infected with delta variant of COVID-19
Alpha variant
Alpha variant is the subtype of SARS CoV-2 virus which is first identified COVID-19 subtype in United Kingdom. Thromboembolic complications of this group were detected among patients which were infected with alpha variant of COVID-19
Other variants
Other variants is the subtype of SARS CoV-2 virus which were identified in Brazil, South Africa..etc. Thromboembolic complications of this group were detected among patients which were infected with alpha variant of COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of thromboembolic complications among patients who effected from different variants of COVID-19 Disease
Time Frame: During the entire intensive care stay up to 1 day
Both arterial and venous thromboembolic events were detected
During the entire intensive care stay up to 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of thromboembolic complications of COVID-19 disease in critically ill patients
Time Frame: During the entire intensive care stay up to 1 day
Both arterial and venous thromboembolic events were detected
During the entire intensive care stay up to 1 day
Rate of thromboembolic complications according to anticoagulant therapy
Time Frame: During the entire intensive care stay up to 1 day
Antithrombotic therapy of each patient was recorded
During the entire intensive care stay up to 1 day
What is the rate of thromboembolism according to the comorbidities
Time Frame: During the entire intensive care stay up to 1 day
Comorbidities of each patient were recorded from the patients records.
During the entire intensive care stay up to 1 day

Collaborators and Investigators

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

Sponsor

Ayse Zeynep Turan

Investigators

  • Principal Investigator: Berna Karakoyun Lacin, Prof., Health and Science University Hamidiye Institute of Health Sciences

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 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DerinceTRH-07

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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