PRecision Ecmo in CardIogenic Shock Evaluation (PRECISE)

February 19, 2023 updated by: Australian and New Zealand Intensive Care Research Centre

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is adult patients on VA-ECMO for cardiogenic shock or cardiac arrest that are or will be enrolled in the national ECMO registry (EXCEL: HREC Project 534/18).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adult patients commencing on VA-ECMO
The study population is adult patients on VA-ECMO for cardiogenic shock or cardiac arrest that are or will be enrolled in the national ECMO registry (EXCEL).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability-free survival at day 180
Time Frame: Day 180
Measured with the World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Australian and New Zealand Intensive Care Research Centre

Investigators

  • Principal Investigator: Aidan JC Burrell, Australian and New Zealand Intensive Care Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 3, 2023

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

February 19, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZIC-RC/AB003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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