Official Title
ECMO Braile Biomédica® in COVID-19 Patients Post-market Clinical Trial to Verify the Performance of the ECMO System
Brief Summary

Retrospective data collection to evaluate the gas transfer capacity of the BraileBiomédica® OxyPrime® ECMO BRCoating® Membrane Oxygenator in COVID-19 patients during thepandemic.

Detailed Description

Multicenter, retrospective, non-comparative, non-randomized study to assess the clinical
performance of the OxyPrime® ECMO BRCoating® Membrane Oxygenator in adult patients with
COVID-19

Status
Recruiting
Conditions
COVID-19
Interventions

Device: Patients underwent cardiorespiratory support

Patients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica®
Membrane Oxygenator

Eligibility Criteria

Inclusion Criteria:

- Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on
ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator, from March 2020
to July 2022, following the Instructions for Use (IFU) of the products.

Exclusion Criteria:

- Patients without a diagnosis of COVID-19

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Locations

Hospital Brasília
Lago Sul, Brasília - DF, Brazil

Investigator: Vitor S Barzilai
Contact: +55 (61) 3305 8208
vitorbarzilai@ictdf.org.br

Contacts

Glacia G Basso
+55(17)2136-7005
glaucia.basso@braile.com.br

Priscila C Joao
+55(17)2136-7005
priscila.joao@braile.com.br

Investigators

Vitor S Barzila, Principal Investigator
Hospital Brasília

Sponsors / Collaborators
Braile Biomedica Ind. Com. e Repr. Ltda.
NCT Number
NCT06086405
Keywords
ECMO
Covid-19
Membrane Oxygenator
MeSH Terms
COVID-19