Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
Study Details
Study Description
Brief Summary
The HETHICO study aims to collect retrospectively documented clinical information on patients hospitalized in Veneto Region (Italy) for SARS-COVID-2 infection in 2 types of settings, medical environment (COORTE MED), and intensive / sub-intensive (COORTE ICU), to assess the safety and possible efficacy of the anticoagulant treatments used for thromboprophylaxis, or in preventing thrombotic complications related to hospitalization from COVID-19.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The HETHICO study aims to collect retrospectively documented clinical information on patients hospitalized in Veneto Region (Italy) for SARS-COVID-2 infection in 2 types of settings, medical environment (COORTE MED), and intensive / sub-intensive (COORTE ICU), to assess the safety and possible efficacy of the anticoagulant treatments used for thromboprophylaxis, or in preventing thrombotic complications related to hospitalization from COVID-19.
Furthermore, the possible association between the observed clinical evolution and the type of antithrombotic prophylaxis performed (class of drug and dose intensity) will be assessed in a large cohort of patients hospitalized in the various participating hospitals in the Veneto region and observed with follow-up. in the short term, gathering information on:
Clinical outcomes, Survival, Concomitant pathologies, Adverse events of anticoagulant drugs, Interactions with other concomitant drugs, and Risk factors.
The collected data, suitably anonymized, will be used to produce scientific works, the standardization of care paths, and the planning of targeted training events.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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MED-Cohort Patients hospitalized for SARS-COVID-2 infection in a medical ward |
Drug: Low Molecular Weight Heparin
Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin
Other Names:
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ICU-Cohort Patients hospitalized for SARS-COVID-2 infection in a sub-intensive or intensive care unit |
Drug: Low Molecular Weight Heparin
Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin
Other Names:
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Outcome Measures
Primary Outcome Measures
- Bleeding [28 days]
Collect and evaluate in real-life the safety data of the anti-coagulant treatments used by estimating the incidence of bleeding complications during hospitalization.
- Thrombosis [28 days]
Collect and evaluate in real-life the efficacy data of the anti-coagulant treatments used by estimating the incidence of deep vein thrombosis and/or pulmonary embolism during hospitalization.
- Mortality [28 days]
Collect and evaluate in real-life the data by estimating incidence of intra-hospital death.
Secondary Outcome Measures
- Worsening [28 days]
clinical worsening with transfer to the intensive/sub-intensive ward
- LOS [60 days]
length of stay
Eligibility Criteria
Criteria
Inclusion Criteria:
- proved SARS-COVID-2 infection
Exclusion Criteria:
- none
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Giuseppe Camporese | Padova | Italy | 35138 |
Sponsors and Collaborators
- Quovadis Associazione
- University of Padova
Investigators
- Principal Investigator: Paolo Simioni, Prof., Department of Medicine, University of Padua (I)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HETHICO