COVID-19, bLOod Coagulation and Thrombosis
CLOT
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
1 other identifier
observational
100
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMay 14, 2020
April 1, 2020
4 months
May 13, 2020
May 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
28 days
Study Arms (1)
Covid Intensive arm
Patients included in intensive care admission by one of the principal investigators from the 3 selectioned centers.
Interventions
Eligibility Criteria
Patient admitted in intensive care
You may qualify if:
- 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.
You may not qualify if:
- Pregnant, lactating or parturient woman
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hôpital Ambroise Paré
Boulogne-Billancourt, IDF, 92100, France
Hôpital Privé Jacques Cartier
Massy, IDF, 91300, France
Centre Cardiologique du Nord
Saint-Denis, IDF, 93200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 14, 2020
Study Start
May 1, 2020
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
May 14, 2020
Record last verified: 2020-04