Study of Hemostasis in Case of Severe COVID-19

• Conditions: COVID-19 Infection

• Registration Number: NCT04359992
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-16
• Study Start: 2020-04-17
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2021-04-17
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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