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COVID-19, bLOod Coagulation and Thrombosis (CLOT)

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ClinicalTrials.gov Identifier: NCT04388657
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin
Information provided by (Responsible Party):
Ramsay Générale de Santé

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.


Condition or disease Intervention/treatment
COVID Embolism and Thrombosis Pneumonia, Viral Diagnostic Test: Echo-Doppler

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Covid Intensive arm
Patients included in intensive care admission by one of the principal investigators from the 3 selectioned centers.
Diagnostic Test: Echo-Doppler
Utrasound Doppler of the lower limbs




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient admitted in intensive care
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388657


Contacts
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Contact: JEAN F OUDET +33683346567 ext +33683346567 jf.oudet@ecten.eu
Contact: MH barba +330664888704 ext +330664888704 mh.barba@ecten.eu

Locations
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France
Hôpital Ambroise Paré Recruiting
Boulogne-Billancourt, IDF, France, 92100
Contact: Guillaume Peri, Dr       guillaume.geri@aphp.fr   
Hôpital Privé Jacques Cartier Recruiting
Massy, IDF, France, 91300
Contact: DRE Ramsay santé       dre@ramsaygds.fr   
Principal Investigator: Wulfran Bougouin         
Centre Cardiologique du Nord Recruiting
Saint-Denis, IDF, France, 93200
Contact: Julien Nahum, Dr       julien@nahum.fr   
Sponsors and Collaborators
Ramsay Générale de Santé
Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin
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Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT04388657    
Other Study ID Numbers: 2020-A00
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Thrombosis
Embolism
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vascular Diseases
Cardiovascular Diseases
Virus Diseases