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Completed

NCT Number: NCT04393805

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hemic and Lymphatic Diseases Hypercoagulability Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombophilia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Giuseppe Camporese

Padova, 35138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • proved SARS-COVID-2 infection

Exclusion criteria

  • none

Treatment and study plan

Low molecular weight heparin

Drug

Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin

Other names: LMWH

Primary outcomes

  1. Bleeding

    Time frame: 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.

  2. Thrombosis

    Time frame: 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.

  3. Mortality

    Time frame: 28 days

    Collect and evaluate in real-life the data by estimating incidence of intra-hospital death.

Secondary outcomes

  1. Worsening

    Time frame: 28 days

    clinical worsening with transfer to the intensive/sub-intensive ward

  2. LOS

    Time frame: 60 days

    length of stay

Sponsors and collaborators

Lead sponsor

Quovadis Associazione

Other

Collaborators

  • University of Padova

Registry information

Acronym: HETHICO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Mar 18, 2021

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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