Our overall objective is to validate the expected 20% reduction of ECMO patients using the ECMO-BIOMARKER companion diagnostic tool. The ECMO-BIOMARKER project seeks to prepare and execute a multi-centre clinical trial (MCCT) with 100 patients.
In a partnership between
• Mermaid Care (DK),
• Aalborg University (DK),
• Imperial College London with the clinical
o Royal Brompton Hospital (UK),
o Medical University of Vienna (AT) and
o Centre Hospitalier Universitaire de Clermont-Ferrand (FR),
we have established a powerful consortium of partners with extensive knowledge and experience in ICU management and ECMO treatment.
In order to execute the ECMO-BIOMARKER project succesfully, several activities are required. Those are:
- Prepare overall project management plan
- Prepare Quality Management plan
- Prepare dissemination plan
- Prepare Data management plan
- Draft a study protocol
- Obtain Ethical Approval for all sites
- Manufacture and install ECMO BIOMARKER systems at all sites and perform training for all staff members including verification of usability
- Initiate study and monitor enrollment, consenting, eCRF fill out etc, and then enroll first patient
- Mid-way interim results UK, FR and Austria
- Final patient enrolled UK, FR and Austria
- Article for journal delivered
- Mermaid Care Business plan updated
Some of the above activities have been executed for this reporting period, and today we have:
- Plans for
o The project management
o The Quality management
o The Dissemination of the results
o The Data management
- A study protocol which has Ethical approval for all sites
- Manufactured and installed ECMO BIOMARKERs at all sites and trained > 85% of all staff members for all sites (target was >75%) and with a usability score of 7.6 across all sites (target was >7, out of 9)
- And finally, our first patient on all sites have been enrolled in the study
So our ECMO-BIOMARKER project is on time and on cost, and we have achieved our deliverables and milestones for this RP1 period as planned.
Covid-19 comments:
In the end of the reporting period, RP1, we have started to face the Covid-19 challenges.
From march 2020, all our consortium partners have been impacted with the Covid-19 pandemic, and we are closely monitoring if the pandemic will have an impact on the execution of this ECMO-BIOMARKER project. In our first reporting period, RP1, it did not, but depending on the various countries lock-downs, and re-prioritization of clinical efforts, it may well have an impact.
If this occurs, it has been agreed between the consortium partners, that the coordinator will approach the Commission and ask for guidance.
