Venous ThromboembolismNCT06806800
Venous Thromboembolism During COVID-19 Pandemic: Evaluation of the Association With the Vaccine and COVID-19 Infection
An observational study of Venous Thromboembolism, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Observational, spontaneous, retrospective, multicenter national study for adult patients, not hospitalized, attending the Thrombo-Embolic Emergency Clinic of the Angiology and Coagulation Disorders Unit (SSD Angiologia e Malattie della Coagulazione) at the IRCCS Azienda Ospedaliero-Universitaria di Bologna, from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 16,000 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2018to 31 Mar 2022
- 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: All adult patients attending the SSD at the IRCCS Azienda Ospedaliero-Universitaria of Bologna from 01/01/2018 to 31/03/2022 will be evaluated. Each patient was managed according to routine clinical practice.
Who may be able to join
- Age ≥ 18 years
- Suspected or requested confirmation of a venous thromboembolic event, as the patient was previously evaluated at another facility and referred to the SSD Angiology and Coagulation Disorders reference center
- Ability to provide informed consent
Who cannot join
- Use of anticoagulants for more than 72 hours prior to presenting at the Thrombo-Embolic Emergency Clinic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Venous Thromboembolism During the COVID-19 Pandemic: Evaluation of the Association With the Vaccine and COVID-19 Infection
Observational, spontaneous, retrospective, multicenter national study for adult patients, not hospitalized, attending the Thrombo-Embolic Emergency Clinic of the Angiology and Coagulation Disorders Unit (SSD Angiologia e Malattie della Coagulazione) at the IRCCS Azienda Ospedaliero-Universitaria di Bologna, from 01/01/2018 to 31/03/2022, in whom venous thromboembolic events were suspected or confirmation was requested, as they were previously seen at another facility and referred to the reference center SSD Angiologia e Malattie della Coagulazione.
To achieve the primary objective, a case-control study will be conducted by cross-referencing data from the outpatient records of the SSD Angiologia e Malattie della Coagulazione from 29/02/2020 to 31/03/2022 with data related to SARS-CoV-2 infections provided by the Public Health Department of the Bologna Local Health Authority (Azienda USL di Bologna).
Read more
Additionally, data from the outpatient records of the SSD Angiologia e Malattie della Coagulazione from 27/12/2020 to 31/03/2022 will be integrated with data on vaccination status, date of administration, and type of vaccine administered, also provided by the Public Health Department of the Bologna Local Health Authority.
To achieve the secondary objective, data from the outpatient records of the SSD Angiologia e Malattie della Coagulazione from 01/01/2018 to 28/02/2020 will be used to describe the patient population attending the clinic during the COVID-19-free period, and will be compared with data from the period 29/02/2020 to 31/03/2022, which corresponds to the COVID-19 period.
Read the detailed description
There are numerous studies exploring the epidemiology and pathophysiology of hypercoagulability associated with Sars-CoV-2 infection, while research is still ongoing to understand the relationship between thromboembolic events and the Covid-19 vaccination. With this study, the investigators aim to confirm the data already present in the literature and examine the association between thromboembolic events and infection or vaccination, focusing on the population residing in the area of the Azienda USL of Bologna.
The study is observational, retrospective, multicenter, and spontaneous, involving adult, non-hospitalized patients attending the Urgent Thromboembolic Care Clinic of the SSD Angiology and Coagulation Diseases at the IRCCS Azienda Ospedaliero-Universitaria of Bologna, from January 1, 2018, to March 31, 2022. Patients are referred to the center for suspected or confirmed venous thromboembolic events after being seen in other facilities. Treatment is provided according to clinical practice, considering the physician's judgment and the information contained in the Technical Sheet of each drug used.
The main objective of the study is achieved through a case-control study, cross-referencing the data from the outpatient reports of the SSD Angiology and Coagulation Diseases (from February 29, 2020, to March 31, 2022) with those related to Sars-CoV-2 infections provided by the Public Health Department of the Azienda USL of Bologna. Additionally, the data on patients' vaccination status, the type of vaccine, and the date of administration (from December 27, 2020, to March 31, 2022) will be integrated.
To reach the secondary objective, the outpatient reports from the pre-Covid period (from January 1, 2018, to February 28, 2020) will be compared with those from the subsequent period (February 29, 2020 - March 31, 2022), which corresponds to the pandemic period. Patients included in the study are those who accessed the Urgent Thromboembolic Care Clinic of the SSD Angiology and Coagulation Diseases, where a venous thromboembolic event was suspected or confirmed. Each patient is followed according to standard care practices, and three distinct periods are analyzed: 1) Covid-19-free period, 2) Covid-19 period, 3) Vaccination period.
The risk factors considered in the study are: Sars-CoV-2 infection confirmed by molecular swab in the 6 months prior to the onset of symptoms (Covid-19 period) and receiving at least one dose of one of the five Covid-19 vaccines authorized in Italy in the 30 days before symptom onset (Vaccination period). Data related to both risk factors are collected from computerized archives provided by the Public Health Department of the Azienda USL of Bologna and linked to patients using the unique identifier of the tax code.
- Conditions
- Venous Thromboembolism
- Keywords
- TVP
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thrombotic events and SARS-CoV-2 infection
The primary objective is to identify venous thrombotic events in patients who have had prior SARS-CoV-2 infection within the previous six months
Measured: Six months prior to enrollment
Venous thrombotic events and anti-SARS-CoV-2 vaccine
The primary objective is to identify venous thrombotic events in patients who have developed symptoms within 30 days of SARS-CoV-2 vaccine administration
Measured: 30 days from SARS-CoV-2 vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start2 Jan 2018
- Primary completion13 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 16,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benilde Cosmi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806800
- Sponsor's protocol ID
- TEVAC-19
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism During the COVID-19 Pandemic: Evaluation of the Association With the Vaccine and COVID-19 Infection
- ClinicalTrials.gov ID
- NCT06806800
- Acronym / sponsor ID
- TEVAC-19
- Conditions
- Venous Thromboembolism
- Keywords
- TVP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,000 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 4 Feb 2025 (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.
Observational, spontaneous, retrospective, multicenter national study for adult patients, not hospitalized, attending the Thrombo-Embolic Emergency Clinic of the Angiology and Coagulation Disorders Unit (SSD Angiologia e Malattie della Coagulazione) at the IRCCS Azienda Ospedaliero-Universitaria di Bologna, from 01/01/2018 to 31/03/2022, in whom venous thromboembolic events were suspected or confirmation was requested, as they were previously seen at another facility and referred to the reference center SSD Angiologia e Malattie della Coagulazione.
To achieve the primary objective, a case-control study will be conducted by cross-referencing data from the outpatient records of the SSD Angiologia e Malattie della Coagulazione from 29/02/2020 to 31/03/2022 with data related to SARS-CoV-2 infections provided by the Public Health Department of the Bologna Local Health Authority (Azienda USL di Bologna).
Additionally, data from the outpatient records of the SSD Angiologia e Malattie della Coagulazione from 27/12/2020 to 31/03/2022 will be integrated with data on vaccination status, date of administration, and type of vaccine administered, also provided by the Public Health Department of the Bologna Local Health Authority.
To achieve the secondary objective, data from the outpatient records of the SSD Angiologia e Malattie della Coagulazione from 01/01/2018 to 28/02/2020 will be used to describe the patient population attending the clinic during the COVID-19-free period, and will be compared with data from the period 29/02/2020 to 31/03/2022, which corresponds to the COVID-19 period.
Detailed description
There are numerous studies exploring the epidemiology and pathophysiology of hypercoagulability associated with Sars-CoV-2 infection, while research is still ongoing to understand the relationship between thromboembolic events and the Covid-19 vaccination. With this study, the investigators aim to confirm the data already present in the literature and examine the association between thromboembolic events and infection or vaccination, focusing on the population residing in the area of the Azienda USL of Bologna.
The study is observational, retrospective, multicenter, and spontaneous, involving adult, non-hospitalized patients attending the Urgent Thromboembolic Care Clinic of the SSD Angiology and Coagulation Diseases at the IRCCS Azienda Ospedaliero-Universitaria of Bologna, from January 1, 2018, to March 31, 2022. Patients are referred to the center for suspected or confirmed venous thromboembolic events after being seen in other facilities. Treatment is provided according to clinical practice, considering the physician's judgment and the information contained in the Technical Sheet of each drug used.
The main objective of the study is achieved through a case-control study, cross-referencing the data from the outpatient reports of the SSD Angiology and Coagulation Diseases (from February 29, 2020, to March 31, 2022) with those related to Sars-CoV-2 infections provided by the Public Health Department of the Azienda USL of Bologna. Additionally, the data on patients' vaccination status, the type of vaccine, and the date of administration (from December 27, 2020, to March 31, 2022) will be integrated.
To reach the secondary objective, the outpatient reports from the pre-Covid period (from January 1, 2018, to February 28, 2020) will be compared with those from the subsequent period (February 29, 2020 - March 31, 2022), which corresponds to the pandemic period. Patients included in the study are those who accessed the Urgent Thromboembolic Care Clinic of the SSD Angiology and Coagulation Diseases, where a venous thromboembolic event was suspected or confirmed. Each patient is followed according to standard care practices, and three distinct periods are analyzed: 1) Covid-19-free period, 2) Covid-19 period, 3) Vaccination period.
The risk factors considered in the study are: Sars-CoV-2 infection confirmed by molecular swab in the 6 months prior to the onset of symptoms (Covid-19 period) and receiving at least one dose of one of the five Covid-19 vaccines authorized in Italy in the 30 days before symptom onset (Vaccination period). Data related to both risk factors are collected from computerized archives provided by the Public Health Department of the Azienda USL of Bologna and linked to patients using the unique identifier of the tax code.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients attending the SSD at the IRCCS Azienda Ospedaliero-Universitaria of Bologna from 01/01/2018 to 31/03/2022 will be evaluated. Each patient was managed according to routine clinical practice.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Suspected or requested confirmation of a venous thromboembolic event, as the patient was previously evaluated at another facility and referred to the SSD Angiology and Coagulation Disorders reference center
- Ability to provide informed consent
Key exclusion criteria (1 listed)
- Use of anticoagulants for more than 72 hours prior to presenting at the Thrombo-Embolic Emergency Clinic.
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
Venous thrombotic events and SARS-CoV-2 infection
Time frame: Six months prior to enrollment
The primary objective is to identify venous thrombotic events in patients who have had prior SARS-CoV-2 infection within the previous six months
Venous thrombotic events and anti-SARS-CoV-2 vaccine
Time frame: 30 days from SARS-CoV-2 vaccine administration
The primary objective is to identify venous thrombotic events in patients who have developed symptoms within 30 days of SARS-CoV-2 vaccine administration
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 10 Feb 2025.
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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.
Benilde Cosmi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Venous Thromboembolism, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 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 10 Feb 2025. 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 Italy. 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?
Venous thrombotic events and SARS-CoV-2 infection (time frame: Six months prior to enrollment). The study lists 2 primary outcomes in all. 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 10 Feb 2025.