NCT06037707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

September 1, 2023

Last Update Submit

January 24, 2024

Conditions

Keywords

COVID-19thromboembolismVariants of COVID-19

Outcome Measures

Primary Outcomes (1)

  • Rate of thromboembolic complications among patients who effected from different variants of COVID-19 Disease

    Both arterial and venous thromboembolic events were detected

    During the entire intensive care stay up to 1 day

Secondary Outcomes (3)

  • Rate of thromboembolic complications of COVID-19 disease in critically ill patients

    During the entire intensive care stay up to 1 day

  • Rate of thromboembolic complications according to anticoagulant therapy

    During the entire intensive care stay up to 1 day

  • What is the rate of thromboembolism according to the comorbidities

    During the entire intensive care stay up to 1 day

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • who is under 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derince Research and Training Hospital

Kocaeli, Derince, 41900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Thromboembolism

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Berna Karakoyun Lacin, Prof.

    Health and Science University Hamidiye Institute of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 14, 2023

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

August 30, 2023

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations