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)

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

Hospital Sírio-Libanês; 🇧🇷 São Paulo, Brazil

Hospital de Campanha Anhembi; 🇧🇷 São Paulo, Brazil

Amager and Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

DRK Kliniken Berlin Köpenick; 🇩🇪 Berlin Köpenick, Germany

DRK Kliniken Berlin Westend; 🇩🇪 Berlin Westend, Germany

Universitätsklinikum Koeln; 🇩🇪 Cologne, Germany

Augusta-Krankenhaus Duesseldorf; 🇩🇪 Duesseldorf, Germany

Universitäts-Herzzentrum Freiburg; 🇩🇪 Freiburg, Germany

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

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