NCT04393805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

May 16, 2020

Last Update Submit

March 17, 2021

Conditions

COVID-19Hypercoagulability

Keywords

COVID-19 pandemicHypercoagulability stateThromboprophylaxisHeparin

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Mortality

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

    28 days

Secondary Outcomes (2)

  • Worsening

    28 days

  • LOS

    60 days

Study Arms (2)

MED-Cohort

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

Drug: Low Molecular Weight Heparin

ICU-Cohort

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

Drug: Low Molecular Weight Heparin

Interventions

Low Molecular Weight HeparinDRUG

Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin

Also known as: LMWH
ICU-CohortMED-Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • proved SARS-COVID-2 infection

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giuseppe Camporese

Padua, 35138, Italy

Location

Related Publications (2)

  • 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.

    PMID: 35244208DERIVED

  • 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.

    PMID: 33502773DERIVED

MeSH Terms

Conditions

COVID-19Thrombophilia

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Paolo Simioni, Prof.

    Department of Medicine, University of Padua (I)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 19, 2020

Study Start

June 1, 2020

Primary Completion

February 26, 2021

Study Completion

February 26, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)