COVID-19HETHICONCT04393805
Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
An observational study of COVID-19 and Hypercoagulability, run by Quovadis Associazione at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Hypercoagulability
- What is being tested?
- Low Molecular Weight Heparin
- How many people
- 744 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 26 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- proved SARS-COVID-2 infection
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19, Hypercoagulability
- Being tested
- Low Molecular Weight Heparin
- Keywords
- COVID-19 pandemic, Hypercoagulability state, Thromboprophylaxis, Heparin
- Medical subject headings
- COVID-19, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Molecular Weight HeparinDrug
Also called LMWH
Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin
| Study group | Role | What they receive |
|---|---|---|
| MED-Cohort | Patients hospitalized for SARS-COVID-2 infection in a medical ward Receives: Drug: Low Molecular Weight Heparin | |
| ICU-Cohort | Patients hospitalized for SARS-COVID-2 infection in a sub-intensive or intensive care unit Receives: Drug: Low Molecular Weight Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Mortality
Collect and evaluate in real-life the data by estimating incidence of intra-hospital death.
Measured: 28 days
Secondary outcomes (2)
Worsening
clinical worsening with transfer to the intensive/sub-intensive ward
Measured: 28 days
LOS
length of stay
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jun 2020
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quovadis Associazione
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Sponsor
- Investigators
- Paolo Simioni, Prof., Principal investigator, Department of Medicine, University of Padua (I)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393805
- Sponsor's protocol ID
- HETHICO
- Acronym
- HETHICO
- Status last verified
- Mar 2021
- First submitted
- 16 May 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Publications
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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208Flumignan 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.
PubMed 33502773
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto
- ClinicalTrials.gov ID
- NCT04393805
- Acronym / sponsor ID
- HETHICO / HETHICO
- Conditions
- COVID-19, Hypercoagulability
- Keywords
- COVID-19 pandemic, Hypercoagulability state, Thromboprophylaxis, Heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Quovadis AssociazioneUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MED-Cohort | – | Drug: Low Molecular Weight HeparinPatients hospitalized for SARS-COVID-2 infection in a medical ward |
| ICU-Cohort | – | Drug: Low Molecular Weight HeparinPatients hospitalized for SARS-COVID-2 infection in a sub-intensive or intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- proved SARS-COVID-2 infection
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Molecular Weight HeparinAlso: LMWHThromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin | Drug | ICU-Cohort, MED-Cohort |
Primary outcome
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.
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.
Mortality
Time frame: 28 days
Collect and evaluate in real-life the data by estimating incidence of intra-hospital death.
2 secondary outcomes
Worsening
Time frame: 28 days
LOS
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 35244208Flumignan 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
- Derived from this study: PubMed 33502773Flumignan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Simioni, Prof. principal investigator
Department of Medicine, University of Padua (I)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Hypercoagulability, run by Quovadis Associazione at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393805, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.