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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03841084




Registration number
NCT03841084
Ethics application status
Date submitted
4/02/2019
Date registered
15/02/2019

Titles & IDs
Public title
Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial
Scientific title
Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial
Secondary ID [1] 0 0
ANZIC-RC/DP001
Universal Trial Number (UTN)
Trial acronym
BLENDER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Failure 0 0
Critical Illness 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oxygen

Active comparator: Conservative Oxygen Management Strategy - Patients allocated to the conservative strategy will have the ECMO blender oxygen fraction (FbO2) will be titrated to achieve a post-oxygenator saturations of 92-96% (the FbO2 cannot be reduced to lower than 0.5). Post-oxygenator arterial blood gases (ABG's) will be taken to ensure safety and to allow for adjustments to be made. The ventilator FiO2 will be titrated to patient oxygen saturations (SpO2) of 92-96%.

Active comparator: Liberal Oxygen Management Strategy - Patients allocated to the liberal strategy will have the FbO2 set at 1.0 at all times. The ventilator FiO2 will be titrated to achieve a patient oxygen saturations (SpO2) of 97-100% (but not lower than 0.5).


Treatment: Drugs: Oxygen
Conservative oxygen management strategy- reduces oxygen on the inoblender in the ECMO circuit.

Liberal oxygen management strategy - does not reduce the oxygen on the inoblender via the ECMO circuit
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary outcome will be the number of alive and ICU-free days to day 28.
Timepoint [1] 0 0
at day 28
Secondary outcome [1] 0 0
Hospital mortality
Timepoint [1] 0 0
at day 28
Secondary outcome [2] 0 0
ICU mortality
Timepoint [2] 0 0
at day 28
Secondary outcome [3] 0 0
ICU length of stay
Timepoint [3] 0 0
at day 28
Secondary outcome [4] 0 0
Duration of mechanical ventilation
Timepoint [4] 0 0
at day 28
Secondary outcome [5] 0 0
Disability
Timepoint [5] 0 0
6 and 12 months
Secondary outcome [6] 0 0
Health-related quality of life at six and twelve months using the EQ5D-5L
Timepoint [6] 0 0
6 and 12 months
Secondary outcome [7] 0 0
Psychological function at six and twelve months
Timepoint [7] 0 0
6 months & 12 months

Eligibility
Key inclusion criteria
• Patients =18 years who are commenced on V-A ECMO for severe cardiac, or following refractory cardiac arrest.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Greater than 6 hours have elapsed from the time of initiation of ECMO to randomisation
* Patients who are suspected or confirmed to be pregnant
* Where an indication exists for a specific oxygen target as part of clinical care (e.g. carbon monoxide poisoning)
* Patients who are already enrolled in another oxygen titration study (unless agreed by study committees)
* Patients not willing to receive blood products (e.g. Jehovah's Witness)
* Where the treating physician deems the study is not in the patient's best interest

Study design
Purpose of the study
Treatment
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2023
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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
David Pilcher
Address 0 0
Monash University, Australian & New Zealand Intensive Care research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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


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/NCT03841084