An observational study in Covid19, Thrombosis and Bleeding, sponsored by University Hospital Dubrava. Active, not recruiting at 1 site in Croatia. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by University Hospital Dubrava · Observational
Aim of this project is to understand clinical features, clinical outcomes and efficacy and safety profiles of different therapies by analyzing a cohort of COVID-19 patients hospitalized and treated in a tertiary-level institution, University hospital Dubrava. Patients' clinical and laboratory characteristics, drug exposure and outcomes are obtained by analysis of written and electronical medical records.
University Hospital Dubrava has been completely repurposed during the COVID-19 pandemic to become high volume COVID-19 tertiary institution. Establishment of hospital registry project is necessary to properly understand disease characteristic, related outcomes and real-life treatment patterns. Registry provides a fundamental framework for future upgrading with emerging or retrogradely obtained specific data that will substantially facilitate understanding of COVID-19 in the context of other specific diseases, therapies and procedures. Large comprehensive database will provide sufficient statistical power to allow for investigation of large number of subgroups and existence of interactions between different variables. Assessment of large number of clinically important outcomes (mortality, occurrence of venous and arterial thromboses, major bleeding, bacteriemia, incidence of mechanical ventilation and intensive care unit admission) is necessary to put any investigated parameter in the proper efficacy and safety context.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 213 across 586 observational studies indexed under Thrombosis.
Browse Thrombosis studies →University Hospital Dubrava is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients that were hospitalized in our institution due to the COVID-19 infection
Exclusion Criteria:
Patients treated with remdesivir due to the COVID-19 infection
Other: Observation
Observation of clinical outcomes and comparison to non-treated patients
Mortality
Incidence of death from any cause
Time frame: At 30-days from hospital admission
Incidence of venous or arterial thrombotic events
Incidence of arterial or venous thromboses proven by objective imaging (ultrasound, computerized tomography, magnetic resonance imaging, scintigraphy) and laboratory (troponin) methods.
Time frame: At 30-days from hospital admission
Incidence of major bleeding
Incidence of bleeding events that can be classified by the International Society on Thrombosis and Haemostasis criteria as major bleeding.
Time frame: At 30-days from hospital admission
Incidence of bacteriemia
Incidence of positive blood cultures that were taken based on clinical suspicion for bacterial co-infection.
Time frame: At 30-days from hospital admission
Incidence of mechanical ventilation
Incidence of mechanical ventilation use required for deteriorating respiratory function.
Time frame: At 30-days from hospital admission
Incidence of intensive care unit admission
Incidence of intensive care unit admission required for intensive/critical level of care.
Time frame: At 30-days from hospital admission
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Dubrava