NCT02527031: APACAR2

A Comparative Study Between a Pre-hospital and an In-hospital Circulatory Support Strategy (ECMO) in Refractory Cardiac Arrest (APACAR2)

Completed NA Last updated 21 September 2022

What this trial tests

NA trial testing ECMO Insertion on pre hospital setting in Cardiac Arrest in 65 participants. Completed in 3 July 2020.

Timeline

29 March 2016

Primary endpoint
26 August 2019

3 July 2020

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	29 March 2016
Primary completion	26 August 2019
Estimated completion	3 July 2020
Sites	1 location across France

Drugs / interventions tested

• ECMO Insertion on pre hospital setting
• In Hospital ECMO

Conditions studied

• Cardiac Arrest — all drugs for Cardiac Arrest →
• Sudden Death — all drugs for Sudden Death →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 65, any sex, with Cardiac Arrest or Sudden Death. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiac arrest (CA) affects approximately 40,000 people in France. It is still a major cause of death in a young population. Management of CA is defined by international recommendations, detailed by learned societies in each country. It includes several links that are interconnected for its optimisation. Despite all these improvements, no progress, or little has been made in the survival of CA victims over the past few years in industrialised countries, and the survival rate in France is 3% to 5%.

Refractory cardiac arrest is defined as failure, after 30 minutes of specialised resuscitation. It used to be the standard to admit that there was no hope of spontaneous cardiac activity and satisfactory neurological recovery after this period, except in cases of CA with neuroprotection (intoxication, hypothermia).

External circulatory support such as "extracorporeal membrane oxygenation" (ECMO) makes it possible to replace the circulatory activity of the myocardium and the respiratory activity of the lungs.

In in-hospital cardiac arrest (CA) some teams use ECMO with an improvement in the survival rate of 20% in comparison to standard resuscitation. This use demonstrates the possibility of neurological recovery independent of the recovery of spontaneous cardiac activity which can be differed.

These results encouraged the use of ECMOs in cases of out-of-hospital refractory cardiac arrests. Patients who are victims of CA are resuscitated for 30 minutes on the spot where the CA occurs. They are then transferred to a specialised centre. The significant improvement in survival noted in in-hospital CAs was not observed in the French series of studies concerning out-of-hospital CAs. This survival is currently estimated at 4%. This difference can be partly explained by the difference in time between the beginning of cardiac massage and the implementation of circulatory support by ECMO ("low flow" period). This time period is directly correlated to survival.

To demonstrate the superiority of this strategy in terms of survival, investigators would like to conduct a randomised comparative study of two strategies: 1) installation of an ECMO between the 20th minute to the 30 minute of CA, directly at the site of the CA, by emergency physicians and/or specifically trained resuscitators 2) On-site resuscitation optimised with secondary transfer to the hospital for the implementation of support. The purpose is to increase by 5% to 20% the survival of victims of out-of-hospital refractory cardiac arrests with a good neurological prognosis.

Main objective:

The hypothesis is that pre-hospital ECMO will result in survival for 20% of the patients, considering that the percentage of survival with in-hospital ECMO is less than 5%.

Main judgement criterion:

Survival with good neurological outcome (CPC 1 or 2) on discharge from intensive care or at 6 months

Secondary judgement criteria:

Success rate of the implementation of ECMO ECMO implementation time Immediate complications: haemorrhage, infection Number of organ harvesting The quality of survivors' neurological status according to the CPC neurological classification at D 28, 2 months and 1 year Predictive indicators of the prognosis during cardiac arrest via cerebral and biological monitoring Methodology, type of study: This is a prospective randomised study of current care Sample size (SS, power, risk): A total number of 105 patients in each group will make it possible to demonstrate at the alpha risk of 5% and a power of 1-β=90%, a significant difference in favour of early pre-hospital ECMO compared to the current practice with in-hospital ECMO.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracorporeal cardiopulmonary resuscitation for cardiac arrest: A systematic review.
   Holmberg MJ, Geri G, Wiberg S, Guerguerian AM, et al · · 2018 · cited 179× · PMID 30063963 · DOI 10.1016/j.resuscitation.2018.07.029
2. Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest in Adult Patients.
   Inoue A, Hifumi T, Sakamoto T, Kuroda Y. · · 2020 · cited 129× · PMID 32204668 · DOI 10.1161/jaha.119.015291
3. In-Depth Extracorporeal Cardiopulmonary Resuscitation in Adult Out-of-Hospital Cardiac Arrest.
   Dennis M, Lal S, Forrest P, Nichol A, et al · · 2020 · cited 55× · PMID 32375010 · DOI 10.1161/jaha.120.016521
4. A systematic review of current ECPR protocols. A step towards standardisation.
   Koen 'J, Nathanaël T, Philippe D. · · 2020 · cited 44× · PMID 34223301 · DOI 10.1016/j.resplu.2020.100018
5. Pre-hospital extra-corporeal cardiopulmonary resuscitation.
   Singer B, Reynolds JC, Lockey DJ, O'Brien B. · · 2018 · cited 40× · PMID 29587810 · DOI 10.1186/s13049-018-0489-y
6. Sub30: Protocol for the Sub30 feasibility study of a pre-hospital Extracorporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 ​min in patients with refractory out-of-hospital cardiac arrest.
   Singer B, Reynolds JC, Davies GE, Wrigley F, et al · · 2020 · cited 28× · PMID 33403364 · DOI 10.1016/j.resplu.2020.100029
7. ECMO in Cardiac Arrest: A Narrative Review of the Literature.
   De Charrière A, Assouline B, Scheen M, Mentha N, et al · · 2021 · cited 26× · PMID 33540537 · DOI 10.3390/jcm10030534
8. Extracorporeal cardiopulmonary resuscitation (eCPR) and cerebral perfusion: A narrative review.
   Justice CN, Halperin HR, Vanden Hoek TL, Geocadin RG. · · 2023 · cited 19× · PMID 36549433 · DOI 10.1016/j.resuscitation.2022.12.009