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

March 17, 2021 updated by: Quovadis Associazione
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

744

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35138
        • Giuseppe Camporese

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • proved SARS-COVID-2 infection

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quovadis Associazione

Collaborators

University of Padova

Investigators

  • Principal Investigator: Paolo Simioni, Prof., Department of Medicine, University of Padua (I)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

February 26, 2021

Study Registration Dates

First Submitted

May 16, 2020

First Submitted That Met QC Criteria

May 16, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HETHICO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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