Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05814094




Registration number
NCT05814094
Ethics application status
Date submitted
22/11/2022
Date registered
14/04/2023

Titles & IDs
Public title
Red Blood Cell Transfusion in ECMO - a Feasibility Trial
Scientific title
Red Blood Cell Transfusion in ECMO - a Feasibility Trial
Secondary ID [1] 0 0
ANZIC-RC/HB001
Universal Trial Number (UTN)
Trial acronym
ROSETTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Loss Anemia 0 0
Extracorporeal Membrane Oxygenation Complication 0 0
Disability Physical 0 0
Cognitive Ability, General 0 0
Functional Status 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Red Blood Cell Transfusion
Other interventions - Red Blood Cell Transfusion

Active comparator: Restrictive Transfusion Trigger Group - 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: Liberal Transfusion Trigger Group - 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: Red Blood Cell Transfusion
Following randomisation, if a patient's Hb concentration reads = 70g/L, one unit of RBC will be transfused within 12 hours of the result becoming available. Additional units can be prescribed if required to raise the Hb concentration to above 70g/L. A transfusion above the restrictive threshold of 70g/L is discouraged.

Other interventions: Red Blood Cell Transfusion
Following randomisation, if a patient's Hb concentration reads = 90g/L, one or more units of RBC will be transfused in order to raise the Hb concentration to greater than 90g/L within 12 hours of the result becoming available. A decision not to transfuse below the threshold of 90g/L is discouraged.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in average lowest daily Hb concentration
Timepoint [1] 0 0
From date of randomization to the end of the intervention (assessed up to day 28)
Secondary outcome [1] 0 0
Enrolment Rate
Timepoint [1] 0 0
through study completion, an average of 2 years
Secondary outcome [2] 0 0
Reasons for not entering eligible patients into the study
Timepoint [2] 0 0
through study completion, an average of 2 years
Secondary outcome [3] 0 0
Mean pre-transfusion Hb concentration immediately prior to an RBC transfusion
Timepoint [3] 0 0
through study completion, an average of 2 years
Secondary outcome [4] 0 0
Proportion of RBC transfusions given according to allocated trigger
Timepoint [4] 0 0
through study completion, an average of 2 years
Secondary outcome [5] 0 0
Time from measured Hb trigger value to transfusion
Timepoint [5] 0 0
through study completion, an average of 2 years
Secondary outcome [6] 0 0
Number of RBC transfusions given prior to randomization
Timepoint [6] 0 0
through study completion, an average of 2 years
Secondary outcome [7] 0 0
Frequency for not transfusing a patient who has reached a transfusion trigger
Timepoint [7] 0 0
through study completion, an average of 2 years
Secondary outcome [8] 0 0
Reason/s for not transfusing a patient who has reached a transfusion trigger
Timepoint [8] 0 0
through study completion, an average of 2 years
Secondary outcome [9] 0 0
Number of protocol deviations
Timepoint [9] 0 0
through study completion, an average of 2 years
Secondary outcome [10] 0 0
Number and nature of Serious Adverse Events (SAEs)
Timepoint [10] 0 0
through study completion, an average of 2 years
Secondary outcome [11] 0 0
Total blood products used
Timepoint [11] 0 0
through study completion, an average of 2 years
Secondary outcome [12] 0 0
Major bleeding events (defined by ISTH criteria)
Timepoint [12] 0 0
through study completion, an average of 2 years
Secondary outcome [13] 0 0
Clinically relevant non-major bleeding events: GI haemorrhage, peripheral cannulation site bleeding, mediastinal cannulation site bleeding, surgical site bleeding
Timepoint [13] 0 0
through study completion, an average of 2 years
Secondary outcome [14] 0 0
Venous and arterial thromboembolic events
Timepoint [14] 0 0
through study completion, an average of 2 years
Secondary outcome [15] 0 0
New onset renal replacement therapy (RRT) during ECMO
Timepoint [15] 0 0
through study completion, an average of 2 years
Secondary outcome [16] 0 0
ECMO free days at day 60
Timepoint [16] 0 0
60 days
Secondary outcome [17] 0 0
ICU free days at day 60
Timepoint [17] 0 0
60 days
Secondary outcome [18] 0 0
Patient Reported Outcome Measure - WHODAS 2.0
Timepoint [18] 0 0
6 months
Secondary outcome [19] 0 0
Patient Reported Outcome Measure - IADL
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Patient Reported Outcome Measure - ADL
Timepoint [20] 0 0
6 months
Secondary outcome [21] 0 0
Patient Reported Outcome Measure - MoCA BLIND
Timepoint [21] 0 0
6 months
Secondary outcome [22] 0 0
Patient Reported Outcome Measure - EQ-5D-5L
Timepoint [22] 0 0
6 months
Secondary outcome [23] 0 0
Patient Reported Outcome Measure - mRS
Timepoint [23] 0 0
6 months

Eligibility
Key inclusion criteria
* Patients receiving ECMO
* Age: 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
* ECMO treatment for more than 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 is defined as the arrival time into the initial ICU.
* The treating physician anticipates that ECMO treatment will cease before the end of tomorrow
* Where the treating physician deems the study is not in the patient's best interest
* Where the treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds
* Patients actively listed for a solid organ transplant
* Patients who are suspected or confirmed to be pregnant
* Previous ECMO treatment during the same hospital admission

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Health Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hergen Buscher, MBBS
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Curtis Hopkins, B.BioMed, MPH, MHA
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0343
Fax 0 0
Email 0 0
anzicrc@monash.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient data is de-identified and only aggregate summaries published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05814094