ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest

NCT ID: NCT04620070

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2025-07-01

Brief Summary

Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs.

Detailed Description

Rationale: Approximately half of all cardiac arrest patients achieve return of spontaneous circulation (ROSC) within 10 minutes. However, If ROSC is not achieved within 20 minutes, favourable neurological outcome is rare. Currently, patients without ROSC at scene die at scene, or are transported (while still in cardiac arrest) to the hospital. In the hospital, advanced life support is continued, or, when presented to selected hospitals capable for this strategy, patients receive Extracorporeal CardioPulmonary Resuscitation (ECPR). ECPR is a strategy in which a miniaturized heart-lung machine (similar to that used in open-heart surgery) is attached to the patient. Nowadays, the greatest drawback transporting OHCA patients with refractory arrest to the hospital are the low quality of thorax compression during transport and long time needed to arrive in the hospital, in part because not all hospitals are able to provide this treatment. In the Netherlands, Helicopter Emergency Medical Services (HEMS) deliver highly specialized medical care to trauma and non-trauma patients, covering the entire country.

Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs.

Objective: To improve survival to hospital discharge and costs/QALY in young patients with OHCA by decreasing the time in cardiac arrest by initiating ECPR on scene.

Conditions

Extracorporeal Membrane Oxygenation; Cardiac Arrest

Keywords

ECPR; prehospital ECPR; out of hospital cardiac arrest

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional

In the Netherlands, out-of-hospital cardiac arrest (OHCA) is managed by paramedics. In this study, in the conventional arm, OHCA is managed by a physician of the Helicopter Emergency Medical Services (HEMS), but without the possibility of prehospital ECPR.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

OHCA managed by the physician of the HEMS team, but with the possibility of prehospital ECPR.

Group Type: EXPERIMENTAL

ECPR

Intervention Type: PROCEDURE

Application of prehospital ECPR

Interventions

ECPR

Application of prehospital ECPR

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• - Age between 18 and 50 years, known or as estimated at inclusion by the HEMS physician.
• Witnessed arrest (last seen well <5 min), OR signs of life (gasping, movement)
• Initial rhyme is VT/VF OR Suspected of having a pulmonary embolism
• Refractory cardiac arrest lasting longer than 20 minutes and shorter than 45 min

If age is not exactly known at inclusion and is estimated by the HEMS physician between 18 and 50 years but finally the patient appears to be younger or older, the patient will not be excluded.

Exclusion Criteria

• - CO2 et<1.2 kPa (10 mmHg) during CPR
• No clear echographic visualisation of either the femoral artery or the femoral vein.
• Expected time from collapse to arrival at an ECPR center with a direct available ECPR team is less than 30 min.

The following patients will be withdrawn after initial inclusion as soon as the following information becomes available:

• Known malignancy
• Known intracranial haemorrhage/ischemia <6 weeks
• Care dependent for daily activities before arrest
• Patients with a "do not resuscitate" order, which was not known at time of the arrest.
• Refusal of deferred consent by the next of kin or by the patient himself to use the data. Deferred consent will not be asked to relatives of patients who die in scene, but are included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Haga Hospital

OTHER

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: collaborator

Isala

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

Amphia ziekenhuis

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dinis Reis Miranda

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dinis Reis Miranda

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Amsterdam UMC

Amsterdam, , Netherlands

UMCG

Groningen, , Netherlands

Radboud

Nijmegen, , Netherlands

ErasmusMC

Rotterdam, , Netherlands

Countries

Netherlands

References

Ali S, Moors X, van Schuppen H, Mommers L, Weelink E, Meuwese CL, Kant M, van den Brule J, Kraemer CE, Vlaar APJ, Akin S, Lansink-Hartgring AO, Scholten E, Otterspoor L, de Metz J, Delnoij T, van Lieshout EMM, Houmes RJ, Hartog DD, Gommers D, Dos Reis Miranda D. A national multi centre pre-hospital ECPR stepped wedge study; design and rationale of the ON-SCENE study. Scand J Trauma Resusc Emerg Med. 2024 Apr 17;32(1):31. doi: 10.1186/s13049-024-01198-x.

Reference Type: DERIVED

PMID: 38632661 (View on PubMed)

Other Identifiers

NL73073.078.20

Identifier Type: -

Identifier Source: org_study_id