COVID-19, bLOod Coagulation and Thrombosis

COVID Clinical Trial

— CLOT  

Official title:

Study of the Prevalence of Deep Vein Thrombosis in Patients Hospitalized in Intensive Care for Acute Respiratory Failure Linked to Pneumonia Documented With SARS-COV2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04388657
• Other study ID #: 2020-A00
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: April 2020
• Source: Ramsay Générale de Santé
• Contact: JEAN F OUDET
• Phone: +33683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).

Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).

This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation.

The main objective is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.

Description:

Coronavirus 2 (SARS-CoV2) has been identified as the pathogen responsible for severe acute respiratory syndrome associated with severe inflammatory syndrome and pneumonia (COVID-19).

Described at the end of 2019 in China, the pandemic sees the number of patients increasing worldwide, Europe being still in the ascending phase of the epidemic and the American continent at the very beginning of it.

Haemostasis abnormalities have been shown to be associated with a poor prognosis in these patients with this pneumonia. In a Chinese series of 183 patients, the hemostasis balance including thrombin time, fibrinogenemia, fibrin degradation products and antithrombin III were within normal limits. Only the D-Dimer assay was positive in the whole cohort with an average rate of 0.66 µg / mL (normal <50 µg / mL). These hemostasis parameters were abnormal mainly in patients who died during their management; the levels of D-dimers and fibrin degradation products were significantly higher while the antithrombin III was reduced. The findings on the particular elevation of D-dimers in deceased patients as well as the significant increase in thrombin time were also reported in another series. Higher numbers of pulmonary embolisms have been reported in patients with severe form of SARS-COV2 (data in press).

This research is based on the hypothesis that the existence of deep vein thrombosis (DVT) could make it possible to screen patients at risk of pulmonary embolism and to set up a curative anticoagulation. This is all the more important since the occurrence of a pulmonary embolism can clearly worsen the right ventricular failure possibly observed during mechanical ventilation in these patients.

Cohort study, non-interventional, multicentric, prospective, non-comparative, longitudinal.

The main objective of the research is to describe the prevalence of deep vein thrombosis in patients hospitalized in intensive care for acute respiratory failure linked to documented SARS-COV2 pneumonia, within 24 hours of their admission.

The secondary objectives of the research are:

• Identify the factors associated with the existence of deep vein thrombosis

• Describe the relationship between the inflammatory status of patients on admission and the existence of DVT during follow-up.

• Describe the relationship between the results of the hemostasis assessment and the existence of deep vein thrombosis during follow-up.

• Describe the relationship between a right ventricular failure or dysfunction during follow-up and the existence of DVT.

• Describe the relationship between mortality and the existence of DVT, within 28 days of the patient's admission to intensive care or intensive care. Describe the lung parenchyma if a CT scan is performed

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient, male or female, over 18 years of age with no upper age limit.

• Patient admitted to intensive care or intensive care for pneumonia linked to SARS-COV2 (diagnosed on positive PCR or chest CT and anamnesis)

• Affiliated patient or beneficiary of a social security scheme

• Patient having been informed and not objecting to the use of their data in the context of this research.

Exclusion Criteria:

• Pregnant, lactating or parturient woman

• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

Related Conditions & MeSH terms

• COVID
• Embolism
• Embolism and Thrombosis
• Pneumonia
• Pneumonia, Viral
• Thrombosis

Intervention

Diagnostic Test:
• Echo-Doppler
Utrasound Doppler of the lower limbs

Locations

Country	Name	City	State
France	Hôpital Ambroise Paré	Boulogne-Billancourt	IDF
France	Hôpital Privé Jacques Cartier	Massy	IDF
France	Centre Cardiologique du Nord	Saint-Denis	IDF

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Hôpital Privé Jacques Cartier, service réanimation Dr Bougouin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with one or more DVTs.	The primary outcome measure will be the percentage of patients with one or more DVTs from a lower extremity ultrasound scan.	28 days