Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto

Conditions
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COVID-19, Hypercoagulability

Intervention / Treatment
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* Drug: Low Molecular Weight Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: proved SARS-COVID-2 infection Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MED-Cohort<br>Patients hospitalized for SARS-COVID-2 infection in a medical ward | Drug: Low Molecular Weight Heparin<br>* Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin<br>* Other names: LMWH;|
| ICU-Cohort<br>Patients hospitalized for SARS-COVID-2 infection in a sub-intensive or intensive care unit | Drug: Low Molecular Weight Heparin<br>* Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin<br>* Other names: LMWH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Collect and evaluate in real-life the safety data of the anti-coagulant treatments used by estimating the incidence of bleeding complications during hospitalization. | 28 days | 
| Thrombosis | 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. | 28 days | 
| Mortality | Collect and evaluate in real-life the data by estimating incidence of intra-hospital death. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening | clinical worsening with transfer to the intensive/sub-intensive ward | 28 days | 
| LOS | length of stay | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 pandemic, Hypercoagulability state, Thromboprophylaxis, Heparin