Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526533
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
RECOMMEND Platform Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reducing Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure RECOMMEND
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOMMEND
Brief Summary:
Patients in the intensive care unit ICU undergoing extracorporeal membrane oxygenation ECMO require close monitoring and interventions to support their recovery The RECOMMEND Platform Trial aims to develop clear high-quality evidence for ECMO care to better inform clinicians in this rapidly evolving field
The RECOMMEND Platform Trial will provide a platform for funding logistics and training protocols This approach enhances efficiency allowing research to begin and complete more efficiently The platform maintains rigorous standards and provides a safe cost-effective and time-efficient method for generating knowledge about ECMO care
Overall platform clinical trials offer a dynamic and innovative approach that enables the simultaneous evaluation of multiple treatments and the rapid translation of scientific discoveries into improved patient care The RECOMMEND Platform Trial has been informed by patient preferences and values and will evaluate the effectiveness and safety of various standards of care This approach supports continuous learning and real-time clinical decision-making to improve patient outcomes
The RECOMMEND Platform Trial will provide a platform for funding logistics and training protocols This approach enhances efficiency allowing research to begin and complete more efficiently The platform maintains rigorous standards and provides a safe cost-effective and time-efficient method for generating knowledge about ECMO care
Overall platform clinical trials offer a dynamic and innovative approach that enables the simultaneous evaluation of multiple treatments and the rapid translation of scientific discoveries into improved patient care The RECOMMEND Platform Trial has been informed by patient preferences and values and will evaluate the effectiveness and safety of various standards of care This approach supports continuous learning and real-time clinical decision-making to improve patient outcomes
Detailed Description:
The RECOMMEND Platform trial is an investigator initiated multicentre open labelled randomised controlled Platform Trial that will utilise Bayesian adaptive logic to investigate the efficacy and safety of multiple study interventions simultaneously or sequentially in cohorts of adult patients who are receiving ECMO from ICUs participating in the national ECMO registry EXCEL in Australian and New Zealand ICU hospitals
In this platform trial various interventions within the scope of standard care will be investigated for their potential to improve outcomes for patients undergoing ECMO Standard care will be used as the common control arm for all intervention cohorts
Extracorporeal Membrane Oxygenation ECMO is an invasive and resource intensive treatment used to support critically ill patients suffering from severe cardiac arrest cardiac failure or respiratory failure ECMO provides mechanical circulatory support temporarily replacing the function of the heart andor lungs allowing time for these organs to recover
Globally the use of ECMO has increased rapidly over the past decade It is both invasive and expensive with the average cost for a single admission in Australia exceeding more than 180000 and a total annual cost of 75 million Despite its high cost ECMO is associated with a high mortality rate and many survivors have compromised functional recovery for months or years after discharge from hospital further adding to the long-terms costs of care
The main complications reported in the national ECMO registry from 2019-2022 include bleeding 514 renal failure and fluid overload 784 and death and ongoing disability 66 These were confirmed as research priorities by consumers and end-users While the use of ECMO increases swiftly the evidence base to support the growing patient numbers receiving this care has not grown at the same rate resulting in important evidence gaps
The RECOMMEND Platform Trial will address these evidence gaps in ECMO services in Australia A platform trial is a type of study design that evaluates multiple treatment interventions for a single condition or device simultaneously within a single overarching framework This framework operates similarly to a standard operating procedure for study logistics ethics management funding staffing and statistical and data collection methods Having an approved process platform for the Platform Trial to operate saves time and money and increases speed of clinical trial onboarding to outcome resolution for researchers hospital staff ethics committees and stakeholders With this platform in place future studies of similar ECMO outcomes can be onboarded more efficiently as described above and it creates a more powerful pool of data for impactful patient-centred research
The aim of the RECOMMEND Platform Trial is to determine in patients with acute cardiorespiratory failure requiring ECMO the efficacy safety and cost-effectiveness of a range of interventions
Over the lifetime of RECOMMEND it is anticipated that new interventions will be added as new domains The creation of new domains will be considered according to priorities set by relevant working groups based on existing or new clinical need and there being sufficient statistical power available within RECOMMEND
In this platform trial various interventions within the scope of standard care will be investigated for their potential to improve outcomes for patients undergoing ECMO Standard care will be used as the common control arm for all intervention cohorts
Extracorporeal Membrane Oxygenation ECMO is an invasive and resource intensive treatment used to support critically ill patients suffering from severe cardiac arrest cardiac failure or respiratory failure ECMO provides mechanical circulatory support temporarily replacing the function of the heart andor lungs allowing time for these organs to recover
Globally the use of ECMO has increased rapidly over the past decade It is both invasive and expensive with the average cost for a single admission in Australia exceeding more than 180000 and a total annual cost of 75 million Despite its high cost ECMO is associated with a high mortality rate and many survivors have compromised functional recovery for months or years after discharge from hospital further adding to the long-terms costs of care
The main complications reported in the national ECMO registry from 2019-2022 include bleeding 514 renal failure and fluid overload 784 and death and ongoing disability 66 These were confirmed as research priorities by consumers and end-users While the use of ECMO increases swiftly the evidence base to support the growing patient numbers receiving this care has not grown at the same rate resulting in important evidence gaps
The RECOMMEND Platform Trial will address these evidence gaps in ECMO services in Australia A platform trial is a type of study design that evaluates multiple treatment interventions for a single condition or device simultaneously within a single overarching framework This framework operates similarly to a standard operating procedure for study logistics ethics management funding staffing and statistical and data collection methods Having an approved process platform for the Platform Trial to operate saves time and money and increases speed of clinical trial onboarding to outcome resolution for researchers hospital staff ethics committees and stakeholders With this platform in place future studies of similar ECMO outcomes can be onboarded more efficiently as described above and it creates a more powerful pool of data for impactful patient-centred research
The aim of the RECOMMEND Platform Trial is to determine in patients with acute cardiorespiratory failure requiring ECMO the efficacy safety and cost-effectiveness of a range of interventions
Over the lifetime of RECOMMEND it is anticipated that new interventions will be added as new domains The creation of new domains will be considered according to priorities set by relevant working groups based on existing or new clinical need and there being sufficient statistical power available within RECOMMEND
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None