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Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04357847
Acronym
Covid-Thelium
Enrollment
100
Registered
2020-04-22
Start date
2020-04-09
Completion date
2021-08-31
Last updated
2021-04-28

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

Conditions

Covid-19, Critically Ill, Endothelial Dysfunction, Thrombosis

Brief summary

The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.

Interventions

None listed

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* all adult patients admitted in ICU for covid-19 disease within the past 24 hrs

Exclusion criteria

* bactrial co-infection at admission * expected death within the next 24 hrs * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality24 hoursPlasma of covid-19 patients will be tested for endothelial injuries, notably with the measurement of InterCellular Adhesion Molecule 1 level by Enzym-Linked Immunosorbent Assay. The association of these levels with 28-days mortality will be evaluated as prognosis markers.

Secondary

MeasureTime frameDescription
Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality24 hoursVascular Endothelial Growth Factor A plasma level will be measured in blood as a marker of endothelial injury expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality24 hoursThis soluble receptor is another marker of endothelial injury and will be measured in blood and expressed as pg/mL. Its association with 28-days mortality will be evaluated.
Association of syndecan -1 plasma level with 28 days mortality24 hourssyndecan -1 is a marker of degradation of glycocalyx, raised during endothelial injury. It will be measured in blood and expressed as pg/mL. Its assocation with 28-days mortality will be evaluated.
Association of Endothelin-1 plasma level with 28 days mortality24 hoursEndothelin-1 will be assessed in blood as a maker of endothelial injuries, expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Association of von Willebrandt Factor with thrombotic events24 hoursThis marker may be raised during endothelial injury and may explained thrombotic status of covid-19 patients. Its blood levels will be measured and expressed as international unit/dL, and correlated with ICAM-1 plasma levels
Association of Viscoelastic testing with thrombotic events24 hoursClot Stiffness and its fibrinogen and platelet contributions (expressed in kPa) will be measured as novative approach, using Quantra (Stago Inc) device, to explore hemostasis alterations of covid-19 patients.
Association of D-dimers plasma levels with thrombotic events24 hoursD-dimers si marker of enhanced thrombotic activity. It may be increased during covid-19 disease but its correlation with endothelial injury is not known. It will be measured in blood and expressed as microgrammes/L, and then correlated with ICAM-1 plasma levels

Countries

France

Contacts

Primary Contactemmanuel besnier, MD
emmanuel.besnier@chu-rouen.fr+33 2 32 88 82 83
Backup Contactthomas clavier, MD, PhD
thomas.clavier@chu-rouen.fr+33 2 32 88 82 83

Outcome results

None listed

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