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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03841084
Ethics application status
Date submitted
4/02/2019
Date registered
15/02/2019
Date last updated
5/11/2019

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 at day 60. - ICU free days are defined as the total number of days (or part days) being free of ICU between randomisation and day 60, with the exception that all patients who die by day 60 will be defined as having zero ICU free days.
Timepoint [1] 0 0
at day 60
Secondary outcome [1] 0 0
Hospital mortality - Mortality rates of patients that day in hospital from randomisation to day 60
Timepoint [1] 0 0
at day 60
Secondary outcome [2] 0 0
ICU mortality - Mortality rates of patients that day in ICU from randomisation to day 60
Timepoint [2] 0 0
at day 60
Secondary outcome [3] 0 0
ICU length of stay - Number of hours spent in ICU from randomisation up to day 60
Timepoint [3] 0 0
at day 60
Secondary outcome [4] 0 0
Duration of mechanical ventilation - Number of hours requiring mechanical ventilation from randomisation to day 60
Timepoint [4] 0 0
at day 60
Secondary outcome [5] 0 0
Disability - World Health Organisation's Disability Assessment Schedule 2.0 12L
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 - Euro Qol Group Health Survey (EQ-5D-5L) Measuring quality of life which looks at five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Timepoint [6] 0 0
6 and 12 months
Secondary outcome [7] 0 0
Psychological function at six and twelve months - Measured using a trained, blinded assessor via telephone interview
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 and/or respiratory
failure or following refractory cardiac arrest.
Minimum age
18 Years
Maximum age
No limit
Gender
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

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
To determine in patients requiring venoarterial (V-A) ECMO, whether the use of a conservative
as compared with liberal oxygen strategy, results in a greater number of ICU-free days at day
60.
Trial website
https://clinicaltrials.gov/show/NCT03841084
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
Kelly Ottosen
Address 0 0
Country 0 0
Phone 0 0
(03) 99030034
Fax 0 0
Email 0 0
kelly.ottosen@monash.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03841084