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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04780295
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Prof. Stavros Konstantinides, MD, Johannes Gutenberg University Mainz

Study Description
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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.

Condition or disease
Covid19

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization: the CORE-THROMBOSIS
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Fatal or non-fatal venous thromboembolism (VTE) [ Time Frame: during index hospitalization for Covid19 ]
  2. Fatal or non-fatal cardiovascular events, encompassing stroke and myocardial infarction [ Time Frame: during index hospitalization for Covid19 ]
  3. All-cause death [ Time Frame: during index hospitalization for Covid19 ]

Secondary Outcome Measures :
  1. Prevalence of cardiovascular risk factors [ Time Frame: at baseline/enrollment ]
  2. Length of hospitalization [ Time Frame: first index hospitalization for Covid19 ]
  3. Prevalent use of in-hospital thromboprophylaxis [ Time Frame: during index hospitalization for Covid19 ]
  4. In-hospital course of D-dimer (μg/mL) [ Time Frame: during index hospitalization for Covid19 ]
  5. In-hospital course of Troponin (ng/ml) [ Time Frame: during index hospitalization for Covid19 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Given the observational nature of this registry, no exclusion criteria will be applied.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780295


Contacts
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Contact: Stavros Konstantinides, MD, Prof +49 6131 17-8382 Stavros.Konstantinides@unimedizin-mainz.de

Locations
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Sponsors and Collaborators
Prof. Stavros Konstantinides, MD
University of Zurich
Investigators
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Study Chair: Stavros Konstantinides, MD, Prof University Medical Center Mainz, Johannes Gutenberg University Mainz
More Information
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Responsible Party: Prof. Stavros Konstantinides, MD, Prof Stavros Konstantinides, MD, Medical Director of the "Center for Thrombosis and Hemostasis" (CTH) at the University Medical Center Mainaz, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04780295    
Other Study ID Numbers: CTH C010
DRKS00022277 ( Registry Identifier: DRKS (Deutsches Register klinischer Studien, engl.: German Clinical Studies Register) )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Stavros Konstantinides, MD, Johannes Gutenberg University Mainz:
Covid19
thromboembolism
thromboprophylaxis
pulmonary embolism
anticoagulation
Additional relevant MeSH terms:
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COVID-19
Thrombosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases