COVID-19-Associated ThromboembolismCOVID-19TCNCT06037707
Thromboembolic Complications in COVID-19 Patients in Intensive Care Unit
An observational study of COVID-19-Associated Thromboembolism, run by Ayse Zeynep Turan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19-Associated Thromboembolism
- How many people
- 484 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients who were infected with COVID-19 and admitted to the intensive care unit between the time of March 2020-December 2021
Who cannot join
- who is under 18 years old.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Research and Training Hospital
Kocaeli, Derince, 41900
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19-Associated Thromboembolism
- Keywords
- COVID-19, thromboembolism, Variants of COVID-19
- Medical subject headings
- COVID-19, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Rate of thromboembolic complications among patients who effected from different variants of COVID-19 Disease
Both arterial and venous thromboembolic events were detected
Measured: 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
Both arterial and venous thromboembolic events were detected
Measured: During the entire intensive care stay up to 1 day
Rate of thromboembolic complications according to anticoagulant therapy
Antithrombotic therapy of each patient was recorded
Measured: During the entire intensive care stay up to 1 day
What is the rate of thromboembolism according to the comorbidities
Comorbidities of each patient were recorded from the patients records.
Measured: During the entire intensive care stay up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19-Associated ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayse Zeynep Turan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayse Zeynep Turan, Derince Training and Research Hospital
- Investigators
- Berna Karakoyun Lacin, Prof., Principal investigator, Health and Science University Hamidiye Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037707
- Sponsor's protocol ID
- DerinceTRH-07
- Acronym
- COVID-19TC
- Status last verified
- Jan 2024
- First submitted
- 1 Sep 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Thromboembolism in COVID-19 Infection in the ICU: a Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT06037707
- Acronym / sponsor ID
- COVID-19TC / DerinceTRH-07
- Conditions
- COVID-19-Associated Thromboembolism
- Keywords
- COVID-19, thromboembolism, Variants of COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Ayse Zeynep TuranUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients who were infected with COVID-19 and admitted to the intensive care unit between the time of March 2020-December 2021
Key exclusion criteria (1 listed)
- who is under 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Rate of thromboembolic complications of COVID-19 disease in critically ill patients
Time frame: 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
What is the rate of thromboembolism according to the comorbidities
Time frame: During the entire intensive care stay up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berna Karakoyun Lacin, Prof. principal investigator
Health and Science University Hamidiye Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19-Associated Thromboembolism, run by Ayse Zeynep Turan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.