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NCT Number: NCT05748860

PRecision Ecmo in CardIogenic Shock Evaluation

Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit.

The PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who will be commencing on VA ECMO (for cardiogenic shock or ECPR)
  • 18 years old or older
  • Patients who will be enrolled in the EXCEL Registry (HREC Project 534/18)

Exclusion criteria

  • Patients who are already on ECMO, or where
  • There are inadequate resources to complete the study

Treatment and study plan

Primary outcomes

  1. Disability-free survival at day 180

    Time frame: Day 180

    Measured with the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)

Study contacts

Contact information is provided by the study sponsor or research team.

Sheraya De Silva

CONTACT

[email protected]

+61 3 9903 0343

Victoria King

CONTACT

[email protected]

+61 3 9905 6646

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Registry information

Acronym: PRECISE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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