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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04366752
Acronym
THROMBOCOVID
Enrollment
130
Registered
2020-04-29
Start date
2020-04-22
Completion date
2020-09-22
Last updated
2023-03-22

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

Conditions

ARDS, Coagulation, COVID-19, Hemostasis, Pneumonia

Keywords

COVID-19, pneumonia, ARDS, venous ultrasound, hemostasis, coagulation

Brief summary

The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of pro-inflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation-induced thrombosis. Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. Very few data are available regarding the biological disorders of coagulation in these patients. Th purpose of this project is to analyze hemostasis and coagulation of patients with infection of COVID-19 and severe pneumonia.

Interventions

Venous ultrasound will be performed on patients once a week, every week from the day of admission in ICU until the day of patient discharge

OTHERblood sample

blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in ICU until the day of patient discharge

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* patients hospitalized in medical ICU with pneumonia due to COVID-19 infection

Exclusion criteria

* patients\< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Variation of thrombin time (in secondes) in Covid-19 patients with pneumonia admitted in ICU.up to 6 weeksThe reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)
Variation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.up to 6 weeksVariation of factor V concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.up to 6 weeksVariation of factor II concentration (U/dL) in Covid-19 patients with pneumonia admitted in ICU.
Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.up to 6 weeksVariation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Covid-19 patients with pneumonia admitted in ICU.

Countries

France

Outcome results

None listed

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