COVID-19, bLOod Coagulation and Thrombosis (CLOT)

May 13, 2020 updated by: Ramsay Générale de Santé

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).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: JEAN F OUDET
  • Phone Number: +33683346567 +33683346567
  • Email: jf.oudet@ecten.eu

Study Locations

  • France
    • IDF
      • Boulogne-Billancourt, IDF, France, 92100
      • Massy, IDF, France, 91300
        • Recruiting
        • Hôpital Privé Jacques Cartier
        • Contact:
        • Principal Investigator:
          • Wulfran Bougouin
      • Saint-Denis, IDF, France, 93200
        • Recruiting
        • Centre Cardiologique du Nord
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient admitted in intensive care

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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