Study of Hemostasis in Case of Severe COVID-19

COVID-19 Infection Clinical Trial

— THROMBOVID  

Official title:

Study of Hemostasis in Case of Severe COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04359992
• Other study ID #: 7774
• Status: Not yet recruiting
• Start date: April 17, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2020
• Source: University Hospital, Strasbourg, France
• Contact: Charles TACQUARD
• Phone: 369551608
• Email: charlesambroise.tacquard[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. Catheter thrombosis and extra-renal purification filters are also abnormally common. These thrombotic complications could contribute to the mortality observed in this pathology. The introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group

Biologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in D-dimers). The presence of circulating anticoagulants is common. Interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent.

In this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2021
• Est. primary completion date: April 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient (<18y)

• With a SARS-CoV-2 infection confirmed by RT-PCR

• Hospitalized in intensive care

Exclusion Criteria:

• Patients under guardianship/curator

• Anemia at 7 g/dL at inclusion

Related Conditions & MeSH terms

• COVID-19 Infection

Intervention

Other:
• Extra blood sample
3 extra blood samples at day 0, 2 and 7

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet activation intensity with the occurrence of clinical thrombotic complications		Change of platelet activity from admission's day in intensive care unit to 2 days and 7 days