BLENDER Trial

Blend to Limit oxygEN in ECMO:

A ranDomised controllEd Registry trial

A Phase II Multicentre Randomised Controlled Trial

Aim: Our aim is to determine in patients requiring venoarterial (V-A) ECMO, whether the use of a conservative as compared with liberal oxygen strategy, results in improved patient outcomes.

Rationale: There is a growing body of evidence that suggests high levels of oxygen may be harmful for our patients. In ECMO patients, the fraction of oxygen in the fresh gas delivered to the membrane (FbO₂) was traditionally maintained at 1.0 (or 100% O₂), however, in recent years a significant number of centres (within Australia and worldwide) are titrating the FbO₂ according to patients’ needs. The variation in clinical practice is a result of the lack of evidence based guidelines. Current ECMO guidelines do not specify an optimal oxygen strategy and clinical equipoise exists.

In the BLENDER Trial we will determine if using a conservative versus a liberal approach to oxygen administration improves patient outcomes. If the BLENDER Trial confirms that one oxygen management strategy is more effective than the other, its findings may improve the lives of critically ill Australians and inform clinical practice worldwide.

Study Completed: Patient recruitment completed in June 2023, with 300 patients enrolled from Victorian and interstate sites across Australia.  Twitter@BLENDER_RCT

Protocol and SAP: Final Protocol and Statistical Analysis Plan Version 5 February 2024, Uploaded 15 February 2024

Publications:

Burrell A, Ng S, Ottosen K, Bailey M, Buscher H, Fraser J, Udy A, Gattas D, Totaro R, Bellomo R, Forrest P, Martin E, Reid L, Ziegenfuss M, Eastwood G, Higgins A, Hodgson C, Litton E, Nair P, Orford N, Pellegrino V, Shekar K, Trapani T, Pilcher D. Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan. Crit Care Resusc 2023;25:118-25. PMID: 37876374. https://www.sciencedirect.com/science/article/pii/S1441277223000224

Burrell A, Ng S, Ottosen K, Bailey M, Buscher H, Fraser J, Udy A, Gattas D, Totaro R, Bellomo R, Forrest P, Martin E, Reid L, Ziegenfuss M, Eastwood G, Higgins A, Hodgson C, Litton E, Nair P, Orford N, Pellegrino V, Shekar K, Trapani T, Pilcher D. Corrigendum to "Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan" [Crit Care Resuscit 25 (2023) 118-125]. Crit Care Resusc 2024;online 1 February. https://www.sciencedirect.com/science/article/pii/S1441277224000036