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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05542966
Registration number
NCT05542966
Ethics application status
Date submitted
13/04/2022
Date registered
16/09/2022
Titles & IDs
Public title
Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
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Scientific title
Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
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Secondary ID [1]
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HREC/50486/Alfred-2019
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Failure
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Critical Illness
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Super oxide dismutase levels U/ml
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Assessment method [1]
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Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
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Timepoint [1]
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Within 24 hours of ECMO commencement
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Secondary outcome [1]
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Marker of Cardiac Injury
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Assessment method [1]
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Troponin ng/ml
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [1]
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Day 3 of ECMO
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Secondary outcome [2]
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Marker of Cardiac Injury
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Assessment method [2]
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Troponin I ng/ml
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [2]
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Day 7 of ECMO
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Secondary outcome [3]
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Markers of Liver Injury
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Assessment method [3]
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ALT and AST (IU/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [3]
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Day 3 of ECMO
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Secondary outcome [4]
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Markers of Liver Injury
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Assessment method [4]
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ALT and AST (IU/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [4]
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Day 7 of ECMO
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Secondary outcome [5]
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Marker of Neurological Injury
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Assessment method [5]
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Neuron Specific Enolase (microg/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [5]
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Day 3 of ECMO
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Secondary outcome [6]
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Marker of Neurological Injury
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Assessment method [6]
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Neuron Specific Enolase (microg/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [6]
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Day 7 of ECMO
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Secondary outcome [7]
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Coagulation Parameters
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Assessment method [7]
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APTT
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [7]
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Day 3 of ECMO
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Secondary outcome [8]
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Coagulation Parameters
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Assessment method [8]
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APTT
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
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Timepoint [8]
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Day 7 of ECMO
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Secondary outcome [9]
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Immune Markers
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Assessment method [9]
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IL-6, TNFa, IL-10, IL-1B (pg/ml)
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Timepoint [9]
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Day 3 of ECMO
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Secondary outcome [10]
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Immune Markers
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Assessment method [10]
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IL-6, TNFa, IL-10, IL-1B (pg/ml)
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Timepoint [10]
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Day 7 of ECMO
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Secondary outcome [11]
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Other Markers of Oxidative Stress
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Assessment method [11]
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Malondialdehyde, Vitamin C
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Timepoint [11]
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Day 3 of ECMO
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Secondary outcome [12]
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Other Markers of Oxidative Stress
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Assessment method [12]
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Malondialdehyde, Vitamin C
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Timepoint [12]
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Day 7 of ECMO
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Secondary outcome [13]
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Superoxide dismutase levels U/ml
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Assessment method [13]
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Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
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Timepoint [13]
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On Day 3 following ECMO commencement
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Secondary outcome [14]
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Superoxide dismutase levels
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Assessment method [14]
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Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
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Timepoint [14]
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On Day 7 following ECMO commencement
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Secondary outcome [15]
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Markers of Kidney Injury
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Assessment method [15]
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Creatinine (micromol/L)
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Timepoint [15]
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Day 3 of ECMO
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Secondary outcome [16]
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Markers of Kidney Injury
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Assessment method [16]
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Creatinine (micromol/L)
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Timepoint [16]
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Day 7 of ECMO
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Eligibility
Key inclusion criteria
* Patients receiving venoarterial (VA) ECMO
* Enrolled in the BLENDER trial
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Not enrolled in the BLENDER trial
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05542966
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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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/NCT05542966