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

January 23, 2023 updated by: Prof. Stavros Konstantinides, MD, Johannes Gutenberg University Mainz

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2708

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Universitatsklinikum Koeln
      • Duesseldorf, Germany, 40472
        • Augusta-Krankenhaus Duesseldorf
      • Freiburg, Germany, 79106
        • Universitäts-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 QuirónSalud
  • Turkey
      • Istanbul, Turkey, 34768
        • Erdem Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatal or non-fatal venous thromboembolism (VTE)
Time Frame: during index hospitalization for Covid19
Rate of thromboembolic events encompassing pulmonary embolism (PE) and deep vein thrombosis (DVT)
during index hospitalization for Covid19
Fatal or non-fatal cardiovascular events
Time Frame: during index hospitalization for Covid19
Rate of cardiovascular events encompassing stroke and myocardial infarction
during index hospitalization for Covid19
All-cause death
Time Frame: during index hospitalization for Covid19
Rate of death from any cause
during index hospitalization for Covid19

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of cardiovascular risk factors
Time Frame: at baseline/enrollment
Baseline prevalence of cardiovascular risk factors and use of specific medications (statins, Angiotensin-converting enzyme [ACE] inhibitors)
at baseline/enrollment
Length of hospitalization
Time Frame: first index hospitalization for Covid19
Duration of inpatient stay
first index hospitalization for Covid19
Prevalent use of in-hospital thromboprophylaxis
Time Frame: 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
during index hospitalization for Covid19
In-hospital course of D-dimer (μg/mL)
Time Frame: during index hospitalization for Covid19
Course of laboratory biomarker
during index hospitalization for Covid19
In-hospital course of Troponin (ng/ml)
Time Frame: during index hospitalization for Covid19
Course of laboratory biomarker
during index hospitalization for Covid19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johannes Gutenberg University Mainz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Stavros Konstantinides, MD, Prof, University Medical Center Mainz, Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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