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Completed

NCT Number: NCT04780295

Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications

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.

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Key information

Conditions

Covid19 COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Pulmonary Embolism RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thromboembolism Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. 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)

  2. Fatal or non-fatal cardiovascular events

    Time frame: during index hospitalization for Covid19

    Rate of cardiovascular events encompassing stroke and myocardial infarction

  3. All-cause death

    Time frame: during index hospitalization for Covid19

    Rate of death from any cause

Secondary outcomes

  1. 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)

  2. Length of hospitalization

    Time frame: first index hospitalization for Covid19

    Duration of inpatient stay

  3. 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

  4. In-hospital course of D-dimer (μg/mL)

    Time frame: during index hospitalization for Covid19

    Course of laboratory biomarker

  5. In-hospital course of Troponin (ng/ml)

    Time frame: during index hospitalization for Covid19

    Course of laboratory biomarker

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • University of Zurich

Registry information

Official study title

COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization

Acronym: CORE-THROMB

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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