Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications (CORE-THROMB)

COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization

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.

Study Overview

• Status: Completed
• Conditions: Covid19

• Study Type: Observational
• Enrollment (Actual): 2708

Contacts and Locations

• Study Contact: Name: Stavros Konstantinides, MD, Prof; Phone Number: +49 6131 17-8382; Email: Stavros.Konstantinides@unimedizin-mainz.de

Study Locations

• Brazil
  • Campinas, Brazil, 13083-970
    • Unicamp (Universidade Estadual de Campinas; University of Campinas)
  • São Paulo, Brazil, 01308-050
    • Hospital Sirio-Libanes
  • São Paulo, Brazil, 02012-021
    • Hospital de Campanha Anhembi
• Denmark
  • Hvidovre, Denmark, 2650
    • Amager and Hvidovre Hospital
• Germany
  • Berlin Köpenick, Germany, 12559
    • DRK Kliniken Berlin Köpenick
  • Berlin Westend, Germany, 14050
    • DRK Kliniken Berlin Westend
  • Cologne, Germany, 50937
    • Universitätsklinikum Koeln
  • Duesseldorf, Germany, 40472
    • Augusta-Krankenhaus Duesseldorf
  • Freiburg, Germany, 79106
    • Universitats-Herzzentrum Freiburg
  • Homburg, Germany, 66421
    • Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
  • Mainz, Germany, 55131
    • Universitätsmedizin Mainz
  • Munich, Germany, 80639
    • Krankenhaus Neuwittelsbach
  • Nuremberg, Germany, 90419
    • Paracelsus Medizinische Privatuniversität am Klinikum Nuernberg
• Ireland
  • Dublin, Ireland
    • Mater Misericordiae University Hospital
• Italy
  • Bologna, Italy, 40126
    • University of Bologna
  • Como, Italy, 22100
    • Azienda Socio Sanitaria Territoriale (ASST) Lariana
  • Erba, Italy, 22036
    • Ospedale Sacra Famiglia Fatebenefratelli
  • Fano, Italy, 61032
    • Presidio Ospedaliero Santa Croce di Fano
  • Genova, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino
  • Guastalla, Italy, 42016
    • Ospedale Civile di Guastalla - Azienda Unità Sanitaria Locale (AUSL) Reggio Emilia
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Parma, Italy, 43126
    • Ospedale Maggiore di Parma - Azienda Ospedaliero Universitaria di Parma
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Piacenza, Italy, 29015
    • Ospedale Civile di Castel San Giovanni - Azienda Unità Sanitaria Locale (AUSL) di Piacenza
  • Reggio Emilia, Italy, 42123
    • Santa Maria Nuova Hospital - Azienda Unità Sanitaria Locale (AUSL) IRCCS di Reggio Emilia
  • Rozzano, Italy, 20089
    • IRCCS Humanitas Clinical and Research Hospital
  • Varese, Italy, 21100
    • Università degli studi dell' Insubria (University of Insubria)
• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Cardiologia Ignacio Chavez (National Institute of Cardiology Igancio Chavez)
• Spain
  • Málaga, Spain, 29004
    • Hospital Quironsalud
• Turkey
  • Istanbul, Turkey, 34768
    • Erdem Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Given the observational nature of this registry, no exclusion criteria will be applied.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: University of Zurich
• Investigators: Study Chair: Stavros Konstantinides, MD, Prof, University Medical Center Mainz, Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): May 18, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Covid19; thromboembolism; anticoagulation; pulmonary embolism; thromboprophylaxis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Embolism and Thrombosis; COVID-19; Thrombosis
• Other Study ID Numbers: CTH C010; DRKS00022277 (Registry Identifier: DRKS (Deutsches Register klinischer Studien, engl.: German Clinical Studies Register))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No