Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications

Completed

• Conditions: Covid19

• Registration Number: NCT04780295
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

This online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (Covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of imaging tests for the detection of cardiovascular events in patients with Covid19. This will also facilitate and constitute the basis for the conduction of interventional thromboprophylaxis studies in patients with Covid19.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-03
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2708

Inclusion Criteria

Hospitalized patients aged ≥ 18 years with a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV2)

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death	during index hospitalization for Covid19	Rate of death from any cause
Fatal or non-fatal venous thromboembolism (VTE)	during index hospitalization for Covid19	Rate of thromboembolic events encompassing pulmonary embolism (PE) and deep vein thrombosis (DVT)
Fatal or non-fatal cardiovascular events	during index hospitalization for Covid19	Rate of cardiovascular events encompassing stroke and myocardial infarction

Secondary Outcome Measures

Name	Time	Method
Prevalence of cardiovascular risk factors	at baseline/enrollment	Baseline prevalence of cardiovascular risk factors and use of specific medications (statins, Angiotensin-converting enzyme \[ACE\] inhibitors)
In-hospital course of D-dimer (μg/mL)	during index hospitalization for Covid19	Course of laboratory biomarker
In-hospital course of Troponin (ng/ml)	during index hospitalization for Covid19	Course of laboratory biomarker
Prevalent use of in-hospital thromboprophylaxis	during index hospitalization for Covid19	Use of unfractionated heparin (UFH), low-molecular weight heparin (LMWH), or direct oral anticoagulants (DOAC) on/after admission due to Covid19
Length of hospitalization	first index hospitalization for Covid19	Duration of inpatient stay

Trial Locations

Locations (30)

Hospital Sírio-Libanês; 🇧🇷 São Paulo, Brazil

Hospital de Campanha Anhembi; 🇧🇷 São Paulo, Brazil

Unicamp (Universidade Estadual de Campinas; University of Campinas); 🇧🇷 Campinas, Brazil

DRK Kliniken Berlin Köpenick; 🇩🇪 Berlin Köpenick, Germany

Universitäts-Herzzentrum Freiburg; 🇩🇪 Freiburg, Germany

DRK Kliniken Berlin Westend; 🇩🇪 Berlin Westend, Germany

Universitätsklinikum Koeln; 🇩🇪 Cologne, Germany

Augusta-Krankenhaus Duesseldorf; 🇩🇪 Duesseldorf, Germany

Universitätsmedizin Mainz; 🇩🇪 Mainz, Germany

Ospedale Sacra Famiglia Fatebenefratelli; 🇮🇹 Erba, Italy

Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes; 🇩🇪 Homburg, Germany

Krankenhaus Neuwittelsbach; 🇩🇪 Munich, Germany

Paracelsus Medizinische Privatuniversität am Klinikum Nuernberg; 🇩🇪 Nuremberg, Germany

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

University of Bologna; 🇮🇹 Bologna, Italy

Instituto Nacional de Cardiologia Ignacio Chavez (National Institute of Cardiology Igancio Chavez); 🇲🇽 Mexico City, Mexico

Erdem Medical Center; 🇹🇷 Istanbul, Turkey

Hospital Quirónsalud; 🇪🇸 Málaga, Spain

Amager and Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Azienda Socio Sanitaria Territoriale (ASST) Lariana; 🇮🇹 Como, Italy

Presidio Ospedaliero Santa Croce di Fano; 🇮🇹 Fano, Italy

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Ospedale Civile di Guastalla - Azienda Unità Sanitaria Locale (AUSL) Reggio Emilia; 🇮🇹 Guastalla, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Ospedale Maggiore di Parma - Azienda Ospedaliero Universitaria di Parma; 🇮🇹 Parma, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ospedale Civile di Castel San Giovanni - Azienda Unità Sanitaria Locale (AUSL) di Piacenza; 🇮🇹 Piacenza, Italy

Santa Maria Nuova Hospital - Azienda Unità Sanitaria Locale (AUSL) IRCCS di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

IRCCS Humanitas Clinical and Research Hospital; 🇮🇹 Rozzano, Italy

Università degli studi dell' Insubria (University of Insubria); 🇮🇹 Varese, Italy