COVIDCLOTNCT04388657
COVID-19, bLOod Coagulation and Thrombosis
An observational study of COVID and Embolism and Thrombosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 3 sites in France.
Trial summary
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19). Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Embolism and Thrombosis, Pneumonia, Viral
- What is being tested?
- Echo-Doppler
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 1 May 2020to 1 Sep 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: Patient admitted in intensive care
Who may be able to join
- Patient, male or female, over 18 years of age with no upper age limit.
- Patient admitted to intensive care or intensive care for pneumonia linked to SARS-COV2 (diagnosed on positive PCR or chest CT and anamnesis)
- Affiliated patient or beneficiary of a social security scheme
- Patient having been informed and not objecting to the use of their data in the context of this research.
Who cannot join
- Pregnant, lactating or parturient woman
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital Ambroise Paré
Boulogne-Billancourt, IDF, 92100
Guillaume Peri, Dr, guillaume.geri@aphp.fr
- Recruiting
Hôpital Privé Jacques Cartier
Massy, IDF, 91300
DRE Ramsay santé, dre@ramsaygds.fr
Wulfran Bougouin
- Recruiting
Centre Cardiologique du Nord
Saint-Denis, IDF, 93200
Julien Nahum, Dr, julien@nahum.fr
About this study
Official title: Study of the Prevalence of Deep Vein Thrombosis in Patients Hospitalized in Intensive Care for Acute Respiratory Failure Linked to Pneumonia Documented With SARS-COV2
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).
Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).
Read more
This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation.
The main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.
Read the detailed description
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).
Described at the end of 2019 in China, the pandemic sees the number of patients increasing worldwide, Europe being still in the ascending phase of the epidemic and the American continent at the very beginning of it.
Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).
This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation. This is all the more important since the occurrence of a pulmonary embolism can clearly worsen the right ventricular failure possibly observed during mechanical ventilation in these patients.
Cohort study, non-interventional, multicentric, prospective, non-comparative, longitudinal.
The main objective of the research is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.
The secondary objectives of the research are:
- Identify the factors associated with the existence of deep vein thrombosis
- Describe the relationship between the inflammatory status of patients on admission and the existence of DVT during follow-up.
- Describe the relationship between the results of the hemostasis assessment and the existence of deep vein thrombosis during follow-up.
- Describe the relationship between a right ventricular failure or dysfunction during follow-up and the existence of DVT.
- Describe the relationship between mortality and the existence of DVT, within 28 days of the patient's admission to intensive care or intensive care. Describe the lung parenchyma if a CT scan is performed
- Conditions
- COVID, Embolism and Thrombosis, Pneumonia, Viral
- Being tested
- Echo-Doppler
- Medical subject headings
- Embolism and Thrombosis, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-DopplerDiagnostic test
Utrasound Doppler of the lower limbs
| Study group | Role | What they receive |
|---|---|---|
| Covid Intensive arm | Patients included in intensive care admission by one of the principal investigators from the 3 selectioned centers. Receives: Diagnostic Test: Echo-Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with one or more DVTs.
The primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 May 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388657
- Sponsor's protocol ID
- 2020-A00
- Acronym
- CLOT
- Status last verified
- Apr 2020
- First submitted
- 13 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Deep Vein Thrombosis in Patients Hospitalized in Intensive Care for Acute Respiratory Failure Linked to Pneumonia Documented With SARS-COV2
- ClinicalTrials.gov ID
- NCT04388657
- Acronym / sponsor ID
- CLOT / 2020-A00
- Conditions
- COVID, Embolism and Thrombosis, Pneumonia, Viral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 14 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.
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).
Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).
This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation.
The main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.
Detailed description
Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).
Described at the end of 2019 in China, the pandemic sees the number of patients increasing worldwide, Europe being still in the ascending phase of the epidemic and the American continent at the very beginning of it.
Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).
This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation. This is all the more important since the occurrence of a pulmonary embolism can clearly worsen the right ventricular failure possibly observed during mechanical ventilation in these patients.
Cohort study, non-interventional, multicentric, prospective, non-comparative, longitudinal.
The main objective of the research is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.
The secondary objectives of the research are:
- Identify the factors associated with the existence of deep vein thrombosis
- Describe the relationship between the inflammatory status of patients on admission and the existence of DVT during follow-up.
- Describe the relationship between the results of the hemostasis assessment and the existence of deep vein thrombosis during follow-up.
- Describe the relationship between a right ventricular failure or dysfunction during follow-up and the existence of DVT.
- Describe the relationship between mortality and the existence of DVT, within 28 days of the patient's admission to intensive care or intensive care. Describe the lung parenchyma if a CT scan is performed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid Intensive arm | – | Diagnostic Test: Echo-DopplerPatients included in intensive care admission by one of the principal investigators from the 3 selectioned centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted in intensive care
Key inclusion criteria (4 listed)
- Patient, male or female, over 18 years of age with no upper age limit.
- Patient admitted to intensive care or intensive care for pneumonia linked to SARS-COV2 (diagnosed on positive PCR or chest CT and anamnesis)
- Affiliated patient or beneficiary of a social security scheme
- Patient having been informed and not objecting to the use of their data in the context of this research.
Key exclusion criteria (2 listed)
- Pregnant, lactating or parturient woman
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
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 |
|---|---|---|
| Echo-DopplerUtrasound Doppler of the lower limbs | Diagnostic test | Covid Intensive arm |
Primary outcome
percentage of patients with one or more DVTs.
Time frame: 28 days
The primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 and Embolism and Thrombosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 3 sites in France.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JEAN F OUDET (+33683346567 ext. +33683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with one or more DVTs. (time frame: 28 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 14 May 2020.