NCT06086405

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 13, 2023

Last Update Submit

October 13, 2023

Conditions

COVID-19

Keywords

ECMOCOVID-19Membrane Oxygenator

Outcome Measures

Primary Outcomes (2)

  • The effectiveness of the oxygenator in ensuring adequate gas exchange

    To ensure adequate oxygenation (post-membrane pO2 \> 150 mmHg during the first week of use) and CO2 elimination (post-membrane pCO2 \< 40 mmHg or pre-membrane pCO2 - post-membrane pCO2 \> 10 mmHg)

    during the first week of use

  • The effectiveness of the set in ensuring adequate flow to the patient

    Nominal flow calculated according to weight or body surface area (50 to 80 mL/Kg or 2.4 L/min of body surface area

    during the use of extracorporeal membrane oxygenation

Secondary Outcomes (6)

  • Rate free of membrane dysfunction

    during the use of extracorporeal membrane oxygenation

  • Need for oxygenator due to dysfunction

    during the use of extracorporeal membrane oxygenation

  • Decannulation rate

    during the use of extracorporeal membrane oxygenation

  • Mortality rate during ECMO use

    during the use of extracorporeal membrane oxygenation

  • Duration of ECMO system usage

    during the use of extracorporeal membrane oxygenation

  • +1 more secondary outcomes

Interventions

Patients underwent cardiorespiratory supportDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without a diagnosis of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Brasília

Lago Sul, Brasília - DF, 71681-603, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Vitor S Barzila

    Hospital Brasília

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Glacia G Basso

CONTACT

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

Priscila C Joao

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 17, 2023

Study Start

September 14, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)