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COVID-19, bLOod Coagulation and Thrombosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04388657
Acronym
CLOT
Enrollment
100
Registered
2020-05-14
Start date
2020-05-01
Completion date
2020-09-01
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, Embolism and Thrombosis, Pneumonia, Viral

Brief 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. 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

Interventions

DIAGNOSTIC_TESTEcho-Doppler

Utrasound Doppler of the lower limbs

Sponsors

Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin
CollaboratorUNKNOWN
Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Pregnant, lactating or parturient woman * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

Design outcomes

Primary

MeasureTime frameDescription
percentage of patients with one or more DVTs.28 daysThe primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.

Countries

France

Contacts

Primary ContactJEAN F OUDET
jf.oudet@ecten.eu+33683346567
Backup ContactMH barba
mh.barba@ecten.eu+330664888704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026