COVID-19ECMO_COVIDNCT06086405
ECMO Braile Biomédica® in COVID-19 Patients
An observational study of COVID-19, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Patients underwent cardiorespiratory support
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Sep 2023to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Patients without a diagnosis of COVID-19
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Brasília
Lago Sul, Brasília - DF, 71681-603
Vitor S Barzilai, +55 (61) 3305 8208 ext. 8209, vitorbarzilai@ictdf.org.br
About this study
Official title: ECMO Braile Biomédica® in COVID-19 Patients Post-market Clinical Trial to Verify the Performance of the ECMO System
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.
Read the 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
- Conditions
- COVID-19
- Being tested
- Patients underwent cardiorespiratory support
- Keywords
- ECMO, COVID-19, Membrane Oxygenator
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients underwent cardiorespiratory supportDevice
Patients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: during the use of extracorporeal membrane oxygenation
Secondary outcomes (6)
Rate free of membrane dysfunction
percentage of oxygenators free from dysfunction
Measured: during the use of extracorporeal membrane oxygenation
Need for oxygenator due to dysfunction
percentage of oxygenators that needed to be replaced due to dysfunction
Measured: during the use of extracorporeal membrane oxygenation
Decannulation rate
percentage of patients who were decannulated from ECMO
Measured: during the use of extracorporeal membrane oxygenation
Mortality rate during ECMO use
percentage of patients who progressed to mortality during ECMO use
Measured: during the use of extracorporeal membrane oxygenation
Duration of ECMO system usage
Total duration of ECMO use (in days)
Measured: during the use of extracorporeal membrane oxygenation
Adverse events during extracorporeal membrane oxygenation use
percentage of adverse events related to the oxygenator
Measured: during the use of extracorporeal membrane oxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start14 Sep 2023
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vitor S Barzila, Principal investigator, Hospital Brasília
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086405
- Sponsor's protocol ID
- ECMO COVID
- Acronym
- ECMO_COVID
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECMO Braile Biomédica® in COVID-19 Patients Post-market Clinical Trial to Verify the Performance of the ECMO System
- ClinicalTrials.gov ID
- NCT06086405
- Acronym / sponsor ID
- ECMO_COVID / ECMO COVID
- Conditions
- COVID-19
- Keywords
- ECMO, COVID-19, Membrane Oxygenator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients without a diagnosis of COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients underwent cardiorespiratory supportPatients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator | Device | – |
Primary outcome
The effectiveness of the oxygenator in ensuring adequate gas exchange
Time frame: during the first week of use
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)
The effectiveness of the set in ensuring adequate flow to the patient
Time frame: during the use of extracorporeal membrane oxygenation
Nominal flow calculated according to weight or body surface area (50 to 80 mL/Kg or 2.4 L/min of body surface area
6 secondary outcomes
Rate free of membrane dysfunction
Time frame: during the use of extracorporeal membrane oxygenation
Need for oxygenator due to dysfunction
Time frame: during the use of extracorporeal membrane oxygenation
Decannulation rate
Time frame: during the use of extracorporeal membrane oxygenation
Mortality rate during ECMO use
Time frame: during the use of extracorporeal membrane oxygenation
Duration of ECMO system usage
Time frame: during the use of extracorporeal membrane oxygenation
Adverse events during extracorporeal membrane oxygenation use
Time frame: during the use of extracorporeal membrane oxygenation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitor S Barzila principal investigator
Hospital Brasília
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Glacia G Basso (+55(17)2136-7005, glaucia.basso@braile.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of the oxygenator in ensuring adequate gas exchange (time frame: during the first week of use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.