Observational Study to Assess Optimal ECPR Settings After Resuscitation (MOFE)

Multi-center Observational Study to Assess Optimal ECMO Settings During the First Hours of Extracorporeal Cardiopulmonary Resuscitation

Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and apoptosis. While performing ECPR, following the European resuscitation guidelines, it is yet unknown how to set the ECMO settings in order to minimize ischemia-reperfusion injury of the brain.

Objective: In this study, we want to elaborate on the optimal ECMO settings in the first three hours after initiation of ECPR.

Study design: Prospective, multi-centre, observational study Study population: All patients receiving ECPR in the age between 18 and 70 years, with low flow duration<60min and receiving cerebral oximetry monitoring Intervention: application of an adhesive regional oximetry sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients.

Main study parameters/endpoints: Cerebral Performance Category at 6 months. Neuron-specific enolase (NSE) will be determined from routine blood drawings.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation
• Intervention / Treatment: Other: Settings of the extracorporeal membrane oxygenation (ECMO)

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015
    • ErasmusMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients receiving ECPR will be included. The decision to perform an ECPR is made by the local protocol and clinical judgment of the attending physician.

Description

Inclusion Criteria:

• Witnessed cardiac arrest or signs of life during CPR (such as gasping or movement)
• Age>18 and < 70 years
• Duration of low-flow < 60 min before decision to proceed with ECPR
• High quality CPR (defined as end-tidal carbon dioxide (CO2et) >10 mmHg) provided for a minimum of 15 minutes without return of spontaneous circulation (ROSC)
• Presumed cardiac cause of cardiac arrest (such as Chest pain before collapse, ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm or ST-elevation on ECG)
• Cerebral oxymetry monitoring initiated during CPR preceding ECPR

Exclusion Criteria:

• Patients with a GCS<15 before CPR.
• Known pre-arrest cerebral performance category CPC ≥ 3
• Presumed noncardiac cause
• Unwitnessed collapse
• Suspected or confirmed pregnancy
• ROSC within 5 minutes of Advanced cardiopulmonary life support (ACLS) performed by emergency medical service (EMS) team
• Conscious patient
• Known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
• Suspected or confirmed acute stroke
• Known severe chronic organ dysfunction or other limitations to therapy
• "Do not resuscitate" order or other circumstances that make 180 day survival unlikely

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ECPR; All patients who received ECMO placement during cardiopulmonary resuscitation (ECPR)	Other: Settings of the extracorporeal membrane oxygenation (ECMO); Compare the settings of the ECMO in different European hospitals and relate them to cerebral saturation and neurological outcome, using Cerebral Performance Category (CPC) score; Other Names: Measurements of cerebral saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPC score 6 months	To prospectively identify parameters correlated with Cerebral Performance Category (CPC)* ≤ 2	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPC score discharge	Parameters correlated with a CPC* ≤ 2	6 months
Glasgow coma scale (GCS) day 28	Parameters correlated with a GCS>13	6 months
GCS total	Parameters correlated with a GCS > 13	6 months
28 day mortality	Parameters correlated to 28 days mortality	6 months
Hospital survival	Parameters correlated to hospital survival	6 months

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Dinis dos Reis Miranda, PhD, MD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2018
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: NL60632.078.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No