Rapid Response VA-ECMO in Refractory Out-of-hospital Cardiac Arrest

NCT03658759 | Withdrawn

• 1 other identifier: ECPR-062018-UAMC
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A selected group of patients with refractory cardiac arrest may benefit from inhospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Many patients will have a coronary event that can be treated by angioplasty. However, up to now absence of ROSC poses a barrier for angioplasty, and most patients are therefore not even transported to a hospital. With the use of extra corporeal membrane oxygenation (ECMO) the circulation can be restored immediately, providing time to diagnose and treat the underlying cause of the cardiac arrest. International cohort studies show that a strategy of pre-hospital triage and transport to a cardiac arrest expertise center for "rapid-response" ECMO and coronary revascularization is feasible and improves survival. A clinical pathway will encompass intense cooperation and optimal logistics between several paramedical and medical disciplines, i.e. from prehospital ambulance service to intensive care. Incorporation of mechanical chest compressions devices (LUCAS™), rapid-response veno-arterial (VA-)ECMO (Cardiohelp, Maquet), and ECMO assisted revascularization in a dedicated clinical pathway will offer a potential lifesaving treatment option that is in accordance with the recommendations in the current Guidelines. The aim of the study is to investigate the feasibility of a new local clinical pathway in our hospital to provide ECPR for refractory OHCA patients.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Extra corporeal Life support; extracorporeal cardiopulmonary resuscitation; refractory out-of-hospital cardiac arrest; extra corporeal membrane oxygenation; mechanical circulatory support; mechanical chest compressions

Outcome Measures

Primary Outcomes (1)

• 1-year mortality

  assessed through study completion: at 1-year.

Secondary Outcomes (10)

• Adverse outcomes

  assessed through study completion: for the time in the hospital , at 30-days and at 1-year.

• Other clinical endpoints: Mortality rate - patients not treated with ECPR in comparison to patients treated with ECPR

  assessed through study completion: at 30-days, at 1-year after inclusion of patient

• Percentage of successful cannulations

  assessed through study completion: at 1 year and at the end of study inclusion period (expected to be at 1.5 years)

• Neurological outcome at 6 months on the cerebral performance category scale (CPC)

  assessed through study completion: at 6 months after inclusion of patient.

• Quality of life at 6 months assessed by Short form 36 (SF-36)

  assessed through study completion: at 6 months after inclusion of patient.

Interventions

Extracorporeal Cardiopulmonary Resuscitation PROCEDURE

local ECPR clinical pathway, including transport with mechanical chest compression device and rapid response VA-ECMO

Also known as: Extra Corporeal Life support, Extra Corporeal Membrane Oxygenation, Mechanical chest compressions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with refractory OHCA due to VF/VT, witnessed cardiac arrest and basic life support before EMS arrival.

You may qualify if:

• Witnessed arrest
• Bystander CPR initiated before EMS arrival or EMS-witnessed arrest
• VF/VT as first recorded rhythm by EMS or shock delivered by AED
• No ROSC within 10 minutes after EMS arrival
• Ambulance transport with mechanical chest compression device

You may not qualify if:

• Confirmation of ROSC
• End-tidal CO2 \< 10 mmHg
• Known terminal disease (eg. cancer)
• Known severe comorbidity
• Severe chronic pulmonary disease (GOLD classification 3 or 4)
• Heart failure NYHA classification 3 or 4
• Known history of bifemoral surgery
• Do Not Resuscitate (DNR) order
• Expected time from transport decision to start ECMO \>60 minute

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Ex utero Intrapartum Treatment Procedures

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fetal Therapies; Therapeutics; Cesarean Section; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jose P.S. Henriques

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. J.P.S. Henriques

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: September 5, 2018
• Study Start: July 2, 2018
• Primary Completion: December 2, 2019
• Study Completion: July 2, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

NL (1)