COVID-19NCT04374617
Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19
An observational study of COVID-19 and Critical Illness, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.
Trial summary
Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Critical Illness, Venous Thromboembolism
- What is being tested?
- Duplex ultrasound and Computed Tomography Angiography
- How many people
- 230 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Apr 2020to 1 May 2020
- 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: Patients with severe COVID-19 pneumonia admitted to the intensive care unit.
Who may be able to join
- Patients with severe COVID-19 pneumonia admitted to the intensive care unit
Who cannot join
- Treatment with Extracorporeal membrane oxygenation (ECMO)
- Pregnant or postpartum women
- Under 18 years old
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona
Badalona, 08916
Vall d´Hebron Research Institute VHIR
Barcelona, Catalonia, 08035
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Barcelona, 08035
About this study
Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.
Read the detailed description
SARS-CoV-2 infection has been associated with coagulation disorders and increased risk of venous thromboembolism (VTE). The aim of the study is to determine the cumulative incidence of VTE in critically ill patients with COVID-19 and its impact on prognosis.
Methods Cohort study of critically ill patients due to COVID-19. A bilateral venous compression (CUS) ultrasound screening of the lower extremities was performed during a cut-off period in 2 intensive care units of university hospitals in Spain. Asymptomatic and symptomatic VTE were registered: pulmonary embolism (PE) (diagnosed by CT-angiography) and deep venous thrombosis (DVT). The characteristics of the patients, results of their blood tests and their evolution after 7 days of follow-up were recorded.
- Conditions
- COVID-19, Critical Illness, Venous Thromboembolism, Venous Thromboses, Venous Thromboses, Deep, Venous Thrombosis Pulmonary
- Being tested
- Duplex ultrasound and Computed Tomography Angiography
- Medical subject headings
- COVID-19, Critical Illness, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Thrombosis, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasound and Computed Tomography AngiographyDiagnostic test
Also called Compression ultrasound (CUS), Ct-Angiography
All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography
| Study group | Role | What they receive |
|---|---|---|
| Venous thromboembolism | Patients at risk of venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) Receives: Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolisms
Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"
Measured: 7 days
Secondary outcomes (1)
Deaths
Deaths from all causes during the follow-up
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Apr 2020
- Primary completion25 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergi Bellmunt, MD,PhD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374617
- Sponsor's protocol ID
- PR(AG)213/2020
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have planned to write a paper
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04374617
- Acronym / sponsor ID
- PR(AG)213/2020
- Conditions
- COVID-19, Critical Illness, Venous Thromboembolism, Venous Thromboses, Venous Thromboses, Deep, Venous Thrombosis Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 5 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.
Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.
Detailed description
SARS-CoV-2 infection has been associated with coagulation disorders and increased risk of venous thromboembolism (VTE). The aim of the study is to determine the cumulative incidence of VTE in critically ill patients with COVID-19 and its impact on prognosis.
Methods Cohort study of critically ill patients due to COVID-19. A bilateral venous compression (CUS) ultrasound screening of the lower extremities was performed during a cut-off period in 2 intensive care units of university hospitals in Spain. Asymptomatic and symptomatic VTE were registered: pulmonary embolism (PE) (diagnosed by CT-angiography) and deep venous thrombosis (DVT). The characteristics of the patients, results of their blood tests and their evolution after 7 days of follow-up were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous thromboembolism | – | Diagnostic Test: Duplex ultrasound and Computed Tomography AngiographyPatients at risk of venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe COVID-19 pneumonia admitted to the intensive care unit.
Key inclusion criteria (1 listed)
- Patients with severe COVID-19 pneumonia admitted to the intensive care unit
Key exclusion criteria (3 listed)
- Treatment with Extracorporeal membrane oxygenation (ECMO)
- Pregnant or postpartum women
- Under 18 years old
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 |
|---|---|---|
| Duplex ultrasound and Computed Tomography AngiographyAlso: Compression ultrasound (CUS), Ct-AngiographyAll venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography | Diagnostic test | Venous thromboembolism |
Primary outcome
Venous thromboembolisms
Time frame: 7 days
Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"
1 secondary outcome
Deaths
Time frame: 7 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 6 May 2020.
- Individual participant dataSharing planned: Undecided. We have planned to write a paper
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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.
Sergi Bellmunt, MD,PhD principal investigator
Hospital Vall d'Hebron
3 sites 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 Critical Illness, run by Hospital Universitari Vall d'Hebron Research Institute at 3 sites in Spain.
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 3 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Venous thromboembolisms (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020.