Extracorporeal Membrane Oxygenation (ECMO) and Coronavirus Disease (COVID) 19

Acute Refractory Heart Failure Related to SARS-CoV 2 Clinical Trial

— ECMO-SARS  

Official title:

Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04397588
• Other study ID #: 35RC20_8979 ECMO-SARS
• Status: Recruiting
• Start date: April 21, 2020
• Est. completion date: October 21, 2020

Study information

• Verified date: May 2020
• Source: Rennes University Hospital
• Contact: Cécile Ferragu
• Phone: 0299282555
• Email: cecile.ferragu[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.

Description:

The main objective of this study is to evaluate the hospital survival of COVID-19 patients supported by venovenous or venoarterial ECMO in a multicenter registry.

The secondary objectives are to describe the characteristics of COVID-19 patients who have received ECMO support, to identify the risk factors associated with hospital mortality, to analyze the outcomes after ECMO weaning including survival at day 28 and day 90, and to analyze the utility of a circulatory support mobile unit in a severe pandemic

Inclusions are both prospective and retrospective in order to collect data over the whole pandemic

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All COVID-19 patients, adults or children,

• Tested positive by RT-PCR for SARS-CoV2 (nasopharyngeal swabs, sputum, endotracheal aspiration, bronchoalveolar lavage or stool sample) and / or with a diagnosis made on chest CT findings,

• Supported by venovenous or venoarterial ECMO

Exclusion Criteria:

• Temporary legally protected Adults over a set period or waiting for protection supervision, guardianship

• Patients or proxies who express their opposition to study participation

Related Conditions & MeSH terms

• Acute Refractory Heart Failure Related to SARS-CoV 2
• ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2
• Coronavirus Infections
• Heart Failure
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Besançon Hospital	Besançon
France	Brest university Hospital	Brest
France	Caen University Hospital	Caen
France	Clermont ferrand University hospital	Clermont-Ferrand
France	APHP Henri Mondor Paris University Hospital	Créteil
France	Dijon University Hospital	Dijon
France	Vendée Hospital	La Roche-sur-Yon
France	Grenoble University Hospital	La Tronche
France	APHP Kremli Bicetre Paris University Hospital	Le Kremlin-Bicêtre
France	Marie Lannelongue Hospital	Le Plessis-Robinson
France	Lens Hospital	Lens
France	Lille University Hospital	Lille
France	Limoges University Hospital	Limoges
France	Clinique de la Sauvegarde	Lyon
France	Lyon University Hospital	Lyon
France	APHM la Timone- Marseille University Hospital	Marseille
France	Clairval Hospital	Marseille
France	Marseille Européen Hospital	Marseille
France	Metz University Hospital	Metz
France	Montpellier University Hospital	Montpellier
France	Emile Muller Hospital	Mulhouse
France	Nancy University Hospital	Nancy
France	Nantes University Hospital	Nantes
France	Ambroise Paré Hospital	Neuilly-sur-Seine
France	Nimes University Hospital	Nimes
France	APHP Bichat - Paris University Hospital	Paris
France	APHP Hopital Européen Georges Pompidou - Paris University Hospital	Paris
France	APHP La Pitié Salpêtrière Paris University Hospital	Paris
France	APHP necker Paris University Hospital	Paris
France	Institut Mutualiste Montsouris	Paris
France	Bordeaux University Hospital	Pessac
France	Poitiers University hospital	Poitiers
France	Reims University hospital	Reims
France	Rennes University hospital	Rennes
France	Rouen University Hospital	Rouen
France	Saint brieuc Hospital	Saint brieuc
France	La Réunion University Hospital	Saint-Denis
France	Saint Etienne University Hospital	Saint-Étienne
France	Saint Nazaire Hospital	Saint-Nazaire
France	Strasbourg University Hospital	Strasbourg
France	Toulouse University Hospital - Rangueil Hospital	Toulouse
France	Tours University Hospital	Tours
France	Bretagne Atlantique Hospital	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality	Hospital mortality	up to 90 days
Secondary	Mortality Day 28	Mortality Day 28	Day 28
Secondary	Mortality Day 90	Mortality Day 90	Day 90
Secondary	Ventilator-free days	Ventilator-free days	Day 28
Secondary	Intensive care unit-free days	ICU-free days	Day 28
Secondary	Hospital-free days	Hospital-free days	Day 28