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

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ClinicalTrials.gov Identifier: NCT04393805
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
University of Padova
Information provided by (Responsible Party):
Quovadis Associazione

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
COVID-19 Hypercoagulability Drug: Low Molecular Weight Heparin

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.

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Study Type : Observational
Estimated Enrollment : 877 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
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 Name: LMWH

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 Name: LMWH




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects of both sexes, aged 18 years or older (no maximum age of inclusion) will be eligible for this study, who have been hospitalized in the participating Operating Units (Centers) of Veneto Region Hospitals with infection SARS-COVID-2.
Criteria

Inclusion Criteria:

  • proved SARS-COVID-2 infection

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393805


Contacts
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Contact: Paolo Simioni, Prof. +39 0498212667 paolo.simioni@unipd.it

Locations
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Italy
Giuseppe Camporese Recruiting
Padova, Italy, 35138
Contact: Giuseppe MD Camporese    ‭+39 049 8212933‬    giuseppe.camporese@aopd.veneto.it   
Sponsors and Collaborators
Quovadis Associazione
University of Padova
Investigators
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Principal Investigator: Paolo Simioni, Prof. Department of Medicine, University of Padua (I)
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Responsible Party: Quovadis Associazione
ClinicalTrials.gov Identifier: NCT04393805    
Other Study ID Numbers: HETHICO
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Quovadis Associazione:
COVID-19 pandemic
Hypercoagulability state
Thromboprophylaxis
Heparin
Additional relevant MeSH terms:
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Thrombophilia
Hematologic Diseases
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action