NCT06806800|Completed
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Sponsor study identifier
observational
16,000
1 country
1
Study Start
January 2, 2018
Actual (reported)Primary Completion
December 13, 2021
Actual (reported)Study Completion
March 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2018
Actual (reported)December 13, 2021
Actual (reported)March 31, 2022
Actual (reported)November 28, 2024
Actual (reported)February 4, 2025
Actual (reported)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
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.
IRCCS Azianda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Benilde Cosmi, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
16,000 participants (actual enrollment reported by the registry).
First Submitted
November 28, 2024
First Posted
February 4, 2025
Study Start
January 2, 2018
Actual (reported)Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism
Contact the study team to confirm eligibility.
Primary Completion
December 13, 2021
Actual (reported)Study Completion
March 31, 2022
Actual (reported)Last Updated
February 10, 2025
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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