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

Sponsor
Quovadis Associazione (Other)
Overall Status
Completed
CT.gov ID
NCT04393805
Collaborator
University of Padova (Other)
744
1
8.9
83.9

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
  • 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.

Study Design

Study Type:
Observational
Actual Enrollment :
744 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Feb 26, 2021
Actual Study Completion Date :
Feb 26, 2021

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • LMWH
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. Mortality [28 days]

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

    Secondary Outcome Measures

    1. Worsening [28 days]

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

    2. LOS [60 days]

      length of stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • proved SARS-COVID-2 infection
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Quovadis Associazione
    ClinicalTrials.gov Identifier:
    NCT04393805
    Other Study ID Numbers:
    • HETHICO
    First Posted:
    May 19, 2020
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Keywords provided by Quovadis Associazione
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2021