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

NCT ID: NCT04393805

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

744 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-02-26

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.

Conditions

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COVID-19 Hypercoagulability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MED-Cohort

Patients hospitalized for SARS-COVID-2 infection in a medical ward

Low Molecular Weight Heparin

Intervention Type DRUG

Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin

ICU-Cohort

Patients hospitalized for SARS-COVID-2 infection in a sub-intensive or intensive care unit

Low Molecular Weight Heparin

Intervention Type DRUG

Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin

Interventions

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Low Molecular Weight Heparin

Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin

Intervention Type DRUG

Other Intervention Names

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LMWH

Eligibility Criteria

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Inclusion Criteria

* proved SARS-COVID-2 infection

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role collaborator

Quovadis Associazione

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paolo Simioni, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, University of Padua (I)

Locations

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Giuseppe Camporese

Padua, , Italy

Site Status

Countries

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Italy

References

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Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

Reference Type DERIVED
PMID: 35244208 (View on PubMed)

Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.

Reference Type DERIVED
PMID: 33502773 (View on PubMed)

Other Identifiers

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HETHICO

Identifier Type: -

Identifier Source: org_study_id

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