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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