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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06526533




Registration number
NCT06526533
Ethics application status
Date submitted
25/07/2024
Date registered
30/07/2024
Date last updated
30/07/2024

Titles & IDs
Public title
RECOMMEND Platform Trial
Scientific title
Reducing Major Complications to Improve the Safety and Efficacy of ECMO in Severe Cardiac and Respiratory Failure (RECOMMEND)
Secondary ID [1] 0 0
ANZIC-RC/CH006
Universal Trial Number (UTN)
Trial acronym
RECOMMEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation Complication 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Liberal Transfusion
Other interventions - Restrictive Transfusion

Active comparator: Blood Transfusion Domain: Red Blood Cell Transfusion in ECMO - Restrictive - This is a domain within the RECOMMEND Platform Trial to test the effectiveness of various blood transfusion strategies for patients with acute cardiorespiratory failure undergoing ECMO treatment in ICU.

Arm details:

The Australian Blood Authority's guidelines recommend a transfusion trigger of haemoglobin (Hb) levels between 70g/L and 90g/L for critically ill patients in ICU. However, this range is broad, and allows great variation in standard care. ROSETTA is a comparative effectiveness trial, assigning patients to two intervention groups that are in the realm of standard care. Participants are patients receiving extracorporeal membrane oxygenation (ECMO) in ICU who are eligible for inclusion in the EXCEL National ECMO Registry.

Trigger:

If a patient's Hb concentration reads = 70g/L, one unit of RBC will be transfused. Additional units can be prescribed if required to raise the Hb concentration to above 70g/L.

Active comparator: Blood Transfusion Domain: Red Blood Cell Transfusion in ECMO - Liberal - This is a domain within the RECOMMEND Platform Trial to test the effectiveness of various blood transfusion strategies for patients with acute cardiorespiratory failure undergoing ECMO treatment in ICU.

Arm details:

The Australian Blood Authority's guidelines recommend a transfusion trigger of haemoglobin (Hb) levels between 70g/L and 90g/L for critically ill patients in ICU. However, this range is broad, and allows great variation in standard care. ROSETTA is a comparative effectiveness trial, assigning patients to two intervention groups that are in the realm of standard care. Participants are patients receiving extracorporeal membrane oxygenation (ECMO) in ICU who are eligible for inclusion in the EXCEL National ECMO Registry.

Trigger:

If a patient's Hb concentration reads = 90g/L, one or more units of RBC will be transfused. Additional units can be prescribed to raise the Hb concentration to greater than 90g/L


Other interventions: Liberal Transfusion
Liberal transfusion trigger group (patient receives RBC transfusion if Hb = 90g/L).

Other interventions: Restrictive Transfusion
Restrictive transfusion trigger group (patient receives RBC transfusion if Hb=70g/L).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Daily Organ Support for patients on ECMO (DOSE-score).
Timepoint [1] 0 0
28-days.
Secondary outcome [1] 0 0
ECMO-related bleeding and thrombotic complications at 28-days.
Timepoint [1] 0 0
28-days.
Secondary outcome [2] 0 0
Mortality at 28-days.
Timepoint [2] 0 0
28-days.
Secondary outcome [3] 0 0
ECMO-free days at 28-days.
Timepoint [3] 0 0
28-days.
Secondary outcome [4] 0 0
Ventilator-free days at 28-days.
Timepoint [4] 0 0
28-days.

Eligibility
Key inclusion criteria
All patients enrolled in the EXCEL Registry (NCT03793257) who meet the inclusion and none of the exclusion criteria are eligible to participate.



* Patients receiving ECMO
* Patients enrolled in the EXCEL Registry
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Treating clinician regards death as imminent and inevitable
* Treating clinician determines it is not in the patient's best interests

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2028
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Sydney
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Alfred
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06526533
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol Hodgson, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sean Bulmer, PhD
Address 0 0
Country 0 0
Phone 0 0
+ 61 437947126
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06526533