Clinical trial NCT04780295: Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications
Official title: COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
thromboembolism
thromboprophylaxis
pulmonary embolism
anticoagulation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2021-03-03
Enrollment: 2708
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Given the observational nature of this registry, no exclusion criteria will be applied.

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.


Eligibility 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

Primary outcomes:
measure: Fatal or non-fatal venous thromboembolism (VTE)
timeFrame: during index hospitalization for Covid19
measure: Fatal or non-fatal cardiovascular events
timeFrame: during index hospitalization for Covid19
measure: All-cause death
timeFrame: during index hospitalization for Covid19
Secondary outcomes:
measure: Prevalence of cardiovascular risk factors
timeFrame: at baseline/enrollment
measure: Length of hospitalization
timeFrame: first index hospitalization for Covid19
measure: Prevalent use of in-hospital thromboprophylaxis
timeFrame: during index hospitalization for Covid19
measure: In-hospital course of D-dimer (μg/mL)
timeFrame: during index hospitalization for Covid19
measure: In-hospital course of Troponin (ng/ml)
timeFrame: during index hospitalization for Covid19
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Unicamp (Universidade Estadual de Campinas; University of Campinas)
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanês
city: São Paulo
country: Brazil
facility: Hospital de Campanha Anhembi
city: Hvidovre
country: Denmark
facility: Amager and Hvidovre Hospital
city: Berlin Köpenick
country: Germany
facility: DRK Kliniken Berlin Köpenick
city: Berlin Westend
country: Germany
facility: DRK Kliniken Berlin Westend
city: Cologne
country: Germany
facility: Universitätsklinikum Koeln
city: Duesseldorf
country: Germany
facility: Augusta-Krankenhaus Duesseldorf
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Munich
country: Germany
facility: Krankenhaus Neuwittelsbach
city: Nuremberg
country: Germany
facility: Paracelsus Medizinische Privatuniversität am Klinikum Nuernberg
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Bologna
country: Italy
facility: University of Bologna
city: Como
country: Italy
facility: Azienda Socio Sanitaria Territoriale (ASST) Lariana
city: Erba
country: Italy
facility: Ospedale Sacra Famiglia Fatebenefratelli
city: Fano
country: Italy
facility: Presidio Ospedaliero Santa Croce di Fano
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Guastalla
country: Italy
facility: Ospedale Civile di Guastalla - Azienda Unità Sanitaria Locale (AUSL) Reggio Emilia
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Parma
country: Italy
facility: Ospedale Maggiore di Parma - Azienda Ospedaliero Universitaria di Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Piacenza
country: Italy
facility: Ospedale Civile di Castel San Giovanni - Azienda Unità Sanitaria Locale (AUSL) di Piacenza
city: Reggio Emilia
country: Italy
facility: Santa Maria Nuova Hospital - Azienda Unità Sanitaria Locale (AUSL) IRCCS di Reggio Emilia
city: Rozzano
country: Italy
facility: IRCCS Humanitas Clinical and Research Hospital
city: Varese
country: Italy
facility: Università degli studi dell' Insubria (University of Insubria)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez (National Institute of Cardiology Igancio Chavez)
city: Málaga
country: Spain
facility: Hospital Quirónsalud
city: Istanbul
country: Turkey
facility: Erdem Medical Center
Study officials:
affiliation: University Medical Center Mainz, Johannes Gutenberg University Mainz
name: Stavros Konstantinides, MD, Prof
role: STUDY_CHAIR
References: