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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04377490
Acronym
THROMBCOVID2
Enrollment
100
Registered
2020-05-06
Start date
2020-05-04
Completion date
2025-11-30
Last updated
2025-05-29

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

Conditions

Coagulation, COVID-19, Hemostasis

Keywords

COVID-19, 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 proinflammatory 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. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19. Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.

Interventions

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

BIOLOGICALblood sample

blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in Amiens Hospital 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

* all patients hospitalized in Amiens Hospital with COVID-19 infection

Exclusion criteria

* patients\< 18 years

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactMichel Slama, Pr
slama.michel@chu-amiens.fr(33)3 22 08 78 41

Outcome results

None listed

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