Venous Thromboembolism During COVID-19 Pandemic: Evaluation of the Association With the Vaccine and COVID-19 Infection

NCT06806800 | Completed

• 1 other identifier: TEVAC-19
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Venous Thromboembolism

Keywords

TVP

Outcome Measures

Primary Outcomes (2)

• 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

  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

  30 days from SARS-CoV-2 vaccine administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Use of anticoagulants for more than 72 hours prior to presenting at the Thrombo-Embolic Emergency Clinic.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azianda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Benilde Cosmi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 4, 2025
• Study Start: January 2, 2018
• Primary Completion: December 13, 2021
• Study Completion: March 31, 2022
• Last Updated: February 10, 2025

Record last verified: 2024-11

Locations

IT (1)