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

COVID-19 Clinical Trial

— HETHICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393805
• Other study ID #: HETHICO
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: February 26, 2021

Study information

• Verified date: March 2021
• Source: Quovadis Associazione
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• proved SARS-COVID-2 infection

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• COVID-19
• Hypercoagulability
• Thrombophilia

Intervention

Drug:
• Low Molecular Weight Heparin
Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin

Locations

Country	Name	City	State
Italy	Giuseppe Camporese	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Quovadis Associazione	University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding	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
Primary	Thrombosis	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
Primary	Mortality	Collect and evaluate in real-life the data by estimating incidence of intra-hospital death.	28 days
Secondary	Worsening	clinical worsening with transfer to the intensive/sub-intensive ward	28 days
Secondary	LOS	length of stay	60 days