Clinical trial NCT04393805: Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
Official title: Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Hypercoagulability
Keywords: COVID-19 pandemic
Hypercoagulability state
Thromboprophylaxis
Heparin
Lead sponsor: Quovadis Associazione
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2020-05-19
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* proved SARS-COVID-2 infection

Exclusion Criteria:

* none

Primary outcomes:
measure: Bleeding
timeFrame: 28 days
measure: Thrombosis
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Worsening
timeFrame: 28 days
measure: LOS
timeFrame: 60 days
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Giuseppe Camporese
Study officials:
affiliation: Department of Medicine, University of Padua (I)
name: Paolo Simioni, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.