Clinical trial

Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial

Name

ANZIC-RC/DP001

Description

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 28.

Trial arms

Trial start

2019-09-18

Estimated PCD

2023-07-03

Trial end

2024-01-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

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

Arms:

Conservative Oxygen Management Strategy, Liberal Oxygen Management Strategy

Size

300

Primary endpoint

The primary outcome will be the number of alive and ICU-free days to day 28.

at day 28

Eligibility criteria

Inclusion Criteria: • Patients ≥18 years who are commenced on V-A ECMO for severe cardiac, or following refractory cardiac arrest. 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a phase II, registry-based, multicentre, parallel group randomised controlled trial.\n\n(Data retrieved from the EXCEL national clinical registry)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}

Updated at

2024-01-30

1 organization

1 product

2 indications

Organization

Australian and New Zealand Intensive Care Research Centre

Product

Oxygen

Indication

Heart Failure

Indication

Critical Illness