Liberal RBC TransfusionRestrictive RBC Transfusion
Liberal RBC Transfusion: Liberal transfusion trigger group (patient receives RBC transfusion if Hb \<90g/L).
Restrictive RBC Transfusion: Restrictive transfusion trigger group (patient receives RBC transfusion if Hb \<70g/L).
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
PLATFORM 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
Primary outcome measure(s)
Daily Organ Support for patients on ECMO (DOSE-score). — 28-days. The primary outcome is the Daily Organ Support for patients on ECMO (DOSE-score), a 6-level daily ordinal outcome measured as the worst status of a patient on each day from day 1 through to day 28 inclusive, which reflects survival, organ support and resource utilisation:
1. dead;
2. on ECMO;
3. invasively mechanically ventilated without ECMO;
4. in ICU but not invasively mechanically ventilated nor on ECMO;
5. in hospital; and
6. discharged from the hospital alive.
Trial sites (3)
Facility
City
Region
Status
Royal Prince Alfred Hospital
Camperdown
New South Wales
Not Yet Recruiting
St. Vincent's Hospital Sydney
Sydney
New South Wales
Recruiting
The Alfred Hospital
Melbourne
Victoria
Not Yet Recruiting
More Australian and New Zealand Intensive Care Research Centre trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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