NCT06177730

Brief Summary

This pilot study aims to determine feasibility of randomising patients to receive pre-hospital Extracorporeal Cardiopulmonary Resuscitation (ECPR) compared to conventional cardiac arrest care for refractory out of hospital cardiac arrest (OHCA). The success of this study will be measured by the number of patients recruited into the study successfully treated with the treatment they were randomised to receive in the pre-Hospital setting.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 11, 2023

Last Update Submit

December 11, 2023

Conditions

Out of Hospital Cardiac Arrest

Keywords

ECMOOHCApre-hospitalExtracorporeal Membrane OxygenationOut of Hospital Cardiac ArrestECPRExtracorproreal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in each group that are successfully initiated on ECMO.

    Proportion of patients in each group that are successfully initiated on ECMO. This will determine if it is feasible to randomise patients to receive either treatment

    6 months

Study Arms (2)

Pre-hospital ECPR Strategy

ACTIVE COMPARATOR

All patients will have high performance CPR at the scene throughout the resuscitation. If the patient is randomised to the Pre-hospital ECPR Strategy, this will be continued until the PACER team arrives. If return of spontaneous circulation (ROSC) has not been achieved at this point, ECPR will be implemented. The patient will be transported to The Alfred Hospital to receive ongoing care.

Other: Pre-Hospital ECPR

Conventional Cardiac Arrest Strategy

NO INTERVENTION

All patients will have high performance CPR at the scene throughout the resuscitation. If the patient has been randomised to the Conventional Cardiac Arrest Strategy and ROSC has not occurred after \>20 minutes, ongoing resuscitation will occur and the patient may be transported via AV to the nearest emergency cardiac catheterisation capable hospital where conventional resuscitation care will continue and Hospital based ECPR may be implemented if the patient meets local eligibility criteria. This is in line with current practice.

Interventions

Pre-Hospital ECPROTHER

Implementation of pre-Hospital ECPr in OHCA

Pre-hospital ECPR Strategy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients 18-70 years old
  • Witnessed cardiac arrest
  • Bystander CPR
  • Refractory cardiac arrest (\>20 mins, but \<45 mins)
  • Initial cardiac rhythm VF, VT or PEA
  • Within hours of PACER service operation (e.g. mon-fri 0800-1700)
  • Within 25 mins of rapid response ambulance (code 1 lights and sirens)

You may not qualify if:

  • Initial cardiac rhythm asystole
  • ROSC with sustained recovery
  • Technically not possible to perform percutaneous cannulation
  • Evidence of/suspectedSignificant end stage disease:
  • Severe disability impairing activities of daily living
  • End-stage organ - cardiac, liver, lung, renal
  • Other life-limiting diseases e.g malignancy, terminal illness
  • Advance health care directive (not for resuscitation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Sacha Richardson, MBBS

    The Alfred

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phoebe McCracken

CONTACT

+61 458 154 740phoebe.mccracken@monash.edu

Tony Trapani

CONTACT

0409798892tony.trapani@monash.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

March 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share