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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05542966




Registration number
NCT05542966
Ethics application status
Date submitted
13/04/2022
Date registered
16/09/2022
Date last updated
26/10/2023

Titles & IDs
Public title
Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
Scientific title
Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
Secondary ID [1] 0 0
HREC/50486/Alfred-2019
Universal Trial Number (UTN)
Trial acronym
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Super oxide dismutase levels U/ml
Timepoint [1] 0 0
Within 24 hours of ECMO commencement
Secondary outcome [1] 0 0
Marker of Cardiac Injury
Timepoint [1] 0 0
Day 3 of ECMO
Secondary outcome [2] 0 0
Marker of Cardiac Injury
Timepoint [2] 0 0
Day 7 of ECMO
Secondary outcome [3] 0 0
Markers of Liver Injury
Timepoint [3] 0 0
Day 3 of ECMO
Secondary outcome [4] 0 0
Markers of Liver Injury
Timepoint [4] 0 0
Day 7 of ECMO
Secondary outcome [5] 0 0
Marker of Neurological Injury
Timepoint [5] 0 0
Day 3 of ECMO
Secondary outcome [6] 0 0
Marker of Neurological Injury
Timepoint [6] 0 0
Day 7 of ECMO
Secondary outcome [7] 0 0
Coagulation Parameters
Timepoint [7] 0 0
Day 3 of ECMO
Secondary outcome [8] 0 0
Coagulation Parameters
Timepoint [8] 0 0
Day 7 of ECMO
Secondary outcome [9] 0 0
Immune Markers
Timepoint [9] 0 0
Day 3 of ECMO
Secondary outcome [10] 0 0
Immune Markers
Timepoint [10] 0 0
Day 7 of ECMO
Secondary outcome [11] 0 0
Other Markers of Oxidative Stress
Timepoint [11] 0 0
Day 3 of ECMO
Secondary outcome [12] 0 0
Other Markers of Oxidative Stress
Timepoint [12] 0 0
Day 7 of ECMO
Secondary outcome [13] 0 0
Superoxide dismutase levels U/ml
Timepoint [13] 0 0
On Day 3 following ECMO commencement
Secondary outcome [14] 0 0
Superoxide dismutase levels
Timepoint [14] 0 0
On Day 7 following ECMO commencement
Secondary outcome [15] 0 0
Markers of Kidney Injury
Timepoint [15] 0 0
Day 3 of ECMO
Secondary outcome [16] 0 0
Markers of Kidney Injury
Timepoint [16] 0 0
Day 7 of ECMO

Eligibility
Key inclusion criteria
- Patients receiving venoarterial (VA) ECMO

- Enrolled in the BLENDER trial
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not enrolled in the BLENDER trial

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - 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 compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress
in patients enrolled in the BLENDER trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05542966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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