COVID-19, bLOod Coagulation and Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

NCT04377490

COVID-19 Hemostasis Coagulation

RECRUITING

Thrombo Embolic Events in Critical Care Patients With Covid-19 Serious Acute Pneumopathy

NCT04366752

COVID-19 Pneumonia ARDS +2 more

COMPLETED

Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With COVID-19 Lung Disease

NCT04479540

Pneumonia, Viral

COMPLETED NA

Thromboembolic Events in Severe COVID-19 Patients

NCT04405869

Pulmonary Thromboembolism

UNKNOWN

Incidence of Acute Pulmonary Embolism in Covid-19 Patients on CT Angiography and Relationship to D-dimer Levels

NCT04373486

Covid-19 With Positive RT-PCR

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

COVID Embolism and Thrombosis Pneumonia, Viral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Covid Intensive arm

Patients included in intensive care admission by one of the principal investigators from the 3 selectioned centers.

Echo-Doppler

Intervention Type DIAGNOSTIC_TEST

Utrasound Doppler of the lower limbs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echo-Doppler

Utrasound Doppler of the lower limbs

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No