RECOMMEND Platform Trial
Recruiting · NCT06526533 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this platform trial is to determine the efficacy, safety and cost-effectiveness of various interventions in patients with acute cardiorespiratory failure requiring extracorporeal membrane oxygenation (ECMO) The main question the platform trial aims to address is to determine the effect of a range of interventions on survival, organ support and resource utilisation to day 28 for hospitalised patients receiving ECMO. Researchers will compare various interventions within multiple platform trial domains to see if the interventions have effects on survival, organ support and resource utilisation for the patient cohort. Participants will be enrolled in accordance with the platform trial's domain structure to answer the research questions.
Who can take part
Inclusion criteria
- Patients receiving ECMO
- Patients enrolled in the EXCEL Registry - NCT03793257
- PLATFORM
Exclusion criteria
- Treating clinician regards death as imminent and inevitable
- Treating clinician determines it is not in the patient's best interests
- RBC TRANSFUSION DOMAIN INCLUSION CRITERIA:
- Aged 18 years or older
- RBC TRANSFUSION DOMAIN EXCLUSION CRITERIA:
- Contraindication to RBC transfusion (including known patient preference)
- Limitations of care put in place either through patient wishes or the treating medical teams.
- Participant has already received ECMO \>12 hours. The start of ECMO is defined as the time of initiation of extracorporeal blood flow unless ECMO was initiated during a surgical intervention in which case the start of ECMO is defined as the arrival time into the initial ICU (post-surgery)
- The treating physician anticipates that ECMO treatment will cease before the end of tomorrow
- The treating physician deems the study is not in the patient's best interest
- The treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds
- Actively listed for a solid organ transplant and has not yet received one
- Suspected or confirmed to be pregnant
- Previous ECMO treatment during the same hospital admission
Where it is running
3 locations listed.
- Royal Prince Alfred Hospital - Camperdown, New South Wales, Australia
- St. Vincent's Hospital Sydney - Sydney, New South Wales, Australia
- The Alfred Hospital - Melbourne, Victoria, Australia