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COVID-19TC: Thromboembolic Complications in COVID-19 Patients in Intensive Care Unit

Sponsor
Ayse Zeynep Turan (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06037707
Collaborator
(none)
484
Enrollment
1
Location
20
Anticipated Duration (Months)
24.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    484 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence of Thromboembolism in COVID-19 Infection in the ICU: a Retrospective Cohort Analysis
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Rate of thromboembolic complications among patients who effected from different variants of COVID-19 Disease [During the entire intensive care stay up to 1 day]

      Both arterial and venous thromboembolic events were detected

    Secondary Outcome Measures

    1. Rate of thromboembolic complications of COVID-19 disease in critically ill patients [During the entire intensive care stay up to 1 day]

      Both arterial and venous thromboembolic events were detected

    2. Rate of thromboembolic complications according to anticoagulant therapy [During the entire intensive care stay up to 1 day]

      Antithrombotic therapy of each patient was recorded

    3. What is the rate of thromboembolism according to the comorbidities [During the entire intensive care stay up to 1 day]

      Comorbidities of each patient were recorded from the patients records.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Derince Research and Training Hospital Kocaeli Derince Turkey 41900

    Sponsors and Collaborators

    • Ayse Zeynep Turan

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayse Zeynep Turan, Principle Investigator, Derince Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT06037707
    Other Study ID Numbers:
    • DerinceTRH-07
    First Posted:
    Sep 14, 2023
    Last Update Posted:
    Sep 14, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayse Zeynep Turan, Principle Investigator, Derince Training and Research Hospital
    COVID-19
    thromboembolism
    Variants of COVID-19
    Additional relevant MeSH terms:
    COVID-19
    Thromboembolism

    Study Results

    No Results Posted as of Sep 14, 2023